Clot retrieval system

ABSTRACT

A platform of devices for removing obstructions and other objects within a blood vessel or other interior lumen of an animal is provided. The system may be deployed in the lumen from a catheter(s) and the system includes a proximal junction, and a distal basket comprised of a plurality of cells. A number of different basket designs are disclosed.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser.16/385,862, filed Apr. 16, 2019 and entitled “CLOT RETRIEVAL SYSTEM”,which is a continuation-in-part of U.S. patent application Ser. No.15/947,955, filed Apr. 9, 2018 and entitled “CLOT RETRIEVAL SYSTEM”,which is a continuation-in-part of U.S. patent application Ser. No.14/794,783, filed Jul. 8, 2015 and entitled “Clot Retrieval System”,which is a continuation-in-part of U.S. patent application Ser. No.14/558,712, filed Dec. 2, 2014 and entitled “CLOT RETRIEVAL SYSTEM,which is a continuation of U.S. patent application Ser. No. 14/558,705,filed Dec. 2, 2014 and entitled “CLOT RETRIEVAL SYSTEM”, which is acontinuation-in-part of U.S. patent application Ser. No. 14/147,491 (nowU.S. Pat. No. 8,900,265), entitled “CLOT RETRIEVAL SYSTEM” and filedJan. 3, 2014. U.S. patent application Ser. No. 14/558,705 further claimspriority under 35 U.S.C. § 119 to U.S. Provisional Patent ApplicationSer. No. 61/994,934, filed May 18, 2014 and entitled “ARTICULATING CLOTRETRIEVAL SYSTEM”. The entire contents of all of the above patentapplications are hereby incorporated by reference.

U.S. patent application Ser. No. 14/794,783 is also acontinuation-in-part of International Patent Application No.PCT/US15/10178, entitled “CLOT RETRIEVAL SYSTEM” and filed Jan. 5, 2015,which is a continuation-in-part of U.S. patent application Ser. No.14/558,712, filed Dec. 2, 2014 and entitled “CLOT RETRIEVAL SYSTEM”,which is a continuation of U.S. patent application Ser. No. 14/558,705,filed Dec. 2, 2014 and entitled “CLOT RETRIEVAL SYSTEM.” U.S. patentapplication Ser. No. 14/558,705 is a continuation-in-part of U.S. patentapplication Ser. No. 14/147,491 (now U.S. Pat. No. 8,900,265), entitled“CLOT RETRIEVAL SYSTEM” and filed Jan. 3, 2014, and further claimspriority under 35 U.S.C. § 119 to U.S. Provisional Patent ApplicationSer. No. 61/994,934, filed May 18, 2014 and entitled “ARTICULATING CLOTRETRIEVAL SYSTEM”. International Patent Application No. PCT/US15/10178further claims priority under 35 U.S.C. § 119 to U.S. patent applicationSer. No. 61/994,919, filed May 18, 2014 and entitled “CLOT RETRIEVALSYSTEM.” The entire contents of all of the above patent applications arehereby incorporated by reference.

U.S. patent application Ser. No. 14/794,783 is also acontinuation-in-part of International Patent Application No.PCT/US15/31447, entitled “CLOT RETRIEVAL SYSTEM” and filed May 18, 2015.The entire contents of all of the above patent applications are herebyincorporated by reference.

BACKGROUND Technical Field

The present invention relates to a deployable system for removing ablood clot or other object from a lumen of an animal.

Background of the Invention

Acute ischemic strokes develop when a blood clot (thrombus) blocks anartery supplying blood to the brain. Needless to say, when a blood clotcreates such a blockage, time in removing the clot is critical.

The removal of intracranial obstructions is limited by several factors,such as the distance of the intracranial obstruction from the femoralaccess site, the tortuosity (twists and turns in the artery as it entersthe base of the skull) of the cervical and proximal intracranialvasculature, the small size of the vessels and the extremely thin wallsof intracranial vessels, which lack a significant muscular layer. Theselimitations require a device to be small and flexible enough to navigatethrough tortuous vessels within a guide catheter and microcatheter,expand after delivery at the site of occlusion and be retrievable intothe microcatheter and yet be strong enough to dislodge strongly adherentthrombus from the vessel wall. In addition, the device should distallyentrap or encase the thrombus to prevent embolization to other vesselsand to completely remove the occlusion. The device should be retrievablewithout the need for proximal occlusion of the vessel, which carriesrisk of further ischemia and risk of vessel injury. The device should besimple to use and be capable of multi-use within the same patienttreatment. The device should not be abrasive and should not have sharpcorners exposed to the endothelial layer of the vessel wall.

Currently available intravascular thrombus and foreign body removaldevices lack several of these features. Currently available devicesinclude the MERCI™ RETRIEVER clot retriever device marketed byConcentric Medical, Inc. (Mountainview, Calif.), the PENUMBRA™ systemmarketed by Penumbra Inc. (Alameda, Calif.) to retrieve clots, and thenewer stent retrieval devices TREVO™ (Stryker, Kalamazoo, Mich.) andSOLITAIRE™ (eV3 Endovascular Inc., Plymouth, Mass., which is asubsidiary of Covidien). All the devices are ineffectual at removingorganized hard thrombus that embolize to the brain from the heart andfrom atherosclerotic proximal vessels. These “hard” thrombi constitutethe majority of strokes which are refractory to medical treatment andare therefore referred for removal by mechanical means through anendovascular approach. The MERCI retrieval system is comprised of coiledspring-like metal and associated suture material. The method of use isdeployment distal to the thrombus and by withdrawing the device throughthe thrombus, the thrombus becomes entangled in the coil and mesh andthen is retrieved. The MERCI system requires occlusion of the proximalvessel with a balloon catheter and simultaneous aspiration of bloodwhile the thrombus is being removed. Most of the time, the device failsto dislodge the thrombus from the wall of the vessel and often, evenwhen successfully dislodging the thrombus, the thrombus embolizes intoanother or the same vessel due to the open ended nature of the device.

The next attempt at a thrombus removal system was the PENUMBRA. ThePENUMBRA is a suction catheter with a separator that macerates thethrombus which is then removed by suction. The device is ineffective atremoving hard, organized thrombus which has embolized from the heart,cholesterol plaque from proximal feeding arteries and other foreignbodies.

The SOLITAIRE and TREVO systems are self-expanding non-detachablestents. The devices are delivered across the thrombus which is thensupposed to become entwined in the mesh of the stent and which is thenremoved in a manner similar to the MERCI system. Again, these devicesare ineffectual at treating hard thrombus. In fact, the thrombus isoften compressed against the vessel wall by the stent which temporarilyopens the vessel by outwardly pressing the clot against the vessel wall.Upon retrieval of the devices, the clot remains or is broken up intoseveral pieces which embolize to vessels further along the vessel.

Thus, there is a need for new, easy-to-use, easy-to-manufacture, safesurgical devices for removing obstructions, such as blood clots, frominternal lumens of humans and other animals in a timely manner.

BRIEF SUMMARY

The present disclosure provides several systems for removingobstructions and other objects within a blood vessel or other lumen ofan animal. The system may be deployed in the lumen from a distal end ofa catheter and, in some embodiments, includes a pull wire having aproximal end and a distal end; a distal body attached to the pull wire,the distal body comprising an interior, an exterior, a proximal end, adistal end, a plurality of proximal memory metal strips located at theproximal end, a proximal hub/junction located in the distal bodyinterior, and a distal hub/junction located distal relative to theproximal hub/junction. The distal body has a relaxed state wherein thedistal body has a first height and width and a collapsed state whereinthe distal body has a second height and width, the second height lessthan said first height, the second width less than the first width. Thesystem further includes a catheter having an interior, a proximal endleading to the interior and a distal end leading to the interior, thecatheter comprised of a biocompatible material and configured toenvelope the distal body when the distal body is in the collapsed state.Each of the proximal memory metal strips has a proximal end and a distalend and preferably, in the relaxed state, each of the proximal ends ofthe proximal memory metal strips is located proximal relative to theproximal hub/junction. Preferably, in the relaxed state, the proximalends of the proximal memory metal strips are configured to move towardseach other and towards the pull wire when an operator moves the proximalhub/junction distally and closer to the stationary distal hub/junction(i.e., when the operator decreases the distance between thehubs/junctions). Preferably, in the relaxed state, the proximal ends ofthe proximal memory metal strips are configured to move away from eachother and away from the pull wire by moving the proximal hub/junctionproximally away from the stationary distal hub/junction (i.e., when theoperator increases the distance between the hubs/junctions).

Optionally, the system further includes a plurality of memory metalconnector strips, the plurality of memory metal connector strips eachhaving a proximal end attached to a proximal memory metal strip and adistal end attached to the proximal hub/junction. Optionally, theconnector strips are integral with the proximal hub/junction (i.e.,optionally, the connector strips and the proximal hub/junction areformed from the same piece of memory metal). Optionally, the proximalhub/junction is a tube having an aperture and the pull wire passesthrough the aperture. Optionally, in the relaxed state, the proximalhub/junction is slideable along the pull wire (i.e., at least a segmentof the pull wire). Optionally, in the relaxed state, the proximal memorymetal strips are distributed substantially evenly about a perimeter ofthe distal body. Optionally, the distal hub/junction is a tube having anaperture. Optionally, the distal hub/junction is attached to the pullwire such that the distal hub/junction is not slideable along the pullwire. Optionally, the distal body further comprises a lead wireextending distally from the distal hub/junction. Optionally, the distalbody comprises a basket comprised of a plurality of memory metal stripsdistal relative to the proximal memory metal strips. Optionally, thedistal hub/junction, the proximal hub/junction, and the distal basketare comprised of a nitinol having the same material composition.Optionally, the distal body further comprises an x-ray marker.Optionally, the proximal memory metal strips form a claw, the clawhaving a closeable proximal end formed by the proximal ends of theproximal memory metal strips. Optionally, between 2 and 4 proximalmemory metal strips form the claw. Optionally, the distal body, in therelaxed state, has a tapered shape in which the distal body height andwidth decrease from the proximal end to the distal end. Optionally, thedistal body, in the relaxed state, has a bullet shape. Optionally, theproximal hub/junction and the distal hub/junction are generallycylindrical in shape and each has an outer diameter and an innerdiameter that forms the apertures of the proximal and distalhub/junctions, the outer diameters of the proximal and distalhub/junctions are substantially the same size, and the inner diametersof the proximal and distal hubs/junctions are substantially the samesize. Optionally, the outer diameters of the proximal and distalhubs/junctions are from about 0.011 inches to about 0.054 inches, andthe inner diameters of the proximal and distal hubs/junctions are fromabout 0.008 inches to about 0.051 inches. Optionally, the pull wire isgenerally cylindrical and the diameter of the pull wire is between about0.008 inches and about 0.051 inches. Optionally, the proximal memorymetal strips have a length of between about 10 and about 60 millimeters.Optionally, the first height and first width of the distal body arebetween about 2 millimeters (mm) and about 6 millimeters. Optionally,the proximal memory metal strips are configured to a separate a clotfrom a blood vessel wall.

The present invention also provides a method of removing an object froman interior lumen of an animal, the lumen having an interior wallforming the lumen. In some embodiments, the method includes:

a) providing a system comprising: i) a pull wire having a proximal endand a distal end; ii) a distal body attached to the pull wire, thedistal body comprising a proximal end, a distal end, and a claw, theclaw comprised of a plurality of memory metal strips, the distal bodyhaving a relaxed state wherein the distal body has a first height andwidth and a collapsed state wherein the distal body has a second heightand width, the second height less than said first height, the secondwidth less than said first width; and iii) a catheter having aninterior, a proximal end leading to the interior and a distal endleading to the interior, the catheter comprised of a biocompatiblematerial and configured to envelope the distal body when said distalbody is in said collapsed state;

b) positioning the system in the lumen;

c) deploying the distal body from the distal end of the catheter;

d) allowing the height and width of said distal body to increase; and

e) moving the memory metal strips towards each other and the pull wireso as to capture the obstruction. Optionally, the claw and the memorymetal strips are located at the proximal end of said distal body and thedistal body is deployed distal to said object. Optionally, the proximalmemory metal strips have a proximal end forming the proximal end of theclaw and a distal end, and the method includes moving the proximal endsof the memory metal strips towards each other and the pull wire so as tocapture the obstruction. Optionally, the distal body further comprises aproximal hub/junction located in the distal body interior, and a distalhub/junction located distal relative to the proximal hub/junction, eachof the memory metal strips has a proximal end and a distal end, each ofthe proximal ends of the memory metal strips is located proximalrelative to the proximal hub/junction, and the proximal ends of thememory metal strips are configured to move towards each other andtowards the pull wire by moving the proximal hub/junction distally andcloser to the distal hub/junction, and the proximal ends of the memorymetal strips are configured to move away from each other and away fromthe pull wire by moving the proximal hub/junction proximally and awayfrom the distal hub/junction, and the method further comprises movingthe proximal hub/junction distally and closer to the distal hub/junctionso as to capture the obstruction in the claw. Optionally, the interiorlumen is an intracranial artery and the obstruction is a blood clot.Optionally, the method further comprises using the clot to move theproximal hub/junction toward the distal hub/junction and exert tensionon the proximal memory metal strips. Optionally, the method furthercomprises using a tube to move the proximal hub/junction toward thedistal hub/junction and exert tension on the proximal memory metalstrips.

The present invention also provides a method of manufacturing a systemfor removing objects within an interior lumen of an animal. In someembodiments, the method includes:

a) providing a single tube comprised of a memory metal, the single tubehaving an exterior, a hollow interior, a wall separating the exteriorfrom the hollow interior, a proximal portion comprising an apertureleading to the hollow interior, a distal portion comprising an apertureleading to the hollow interior, and a middle portion between theproximal portion and the distal portion;

b) cutting the wall of the middle portion with a laser;

c) removing the pieces of the middle portion cut by the laser to form aproximal tube, a middle portion comprising a plurality of memory metalstrips attached to the proximal tube and a distal tube;

d) altering the shape of the middle portion;

e) allowing the middle portion to expand relative to the distal tube andthe proximal tube;

f) cutting the memory metal strips to form a first segment comprisingthe proximal tube and a proximal segment of the memory metal strips, anda second segment comprising the distal tube and a distal segment of thememory metal strips; and

g) joining the proximal segments to the distal segments such that thedistal segments form the proximal end of a distal body, such that theproximal tube is located inside an interior of said distal body, andsuch that the proximal tube is located distal relative to the proximalend.

Optionally, the method further includes placing a pull wire through theproximal tube such that the proximal tube is slideable along at least asegment of the pull wire. Optionally, the method further includesattaching the pull wire to the distal tube. Optionally, the step ofjoining the proximal segments to the distal segments comprises weldingor soldering the proximal segments to the distal segments. Optionally,after the step of joining the proximal segments to the distal segments,the proximal end forms a claw comprised of between 2 and 4 memory metalstrips, the claw memory metal strips configured to move towards each bymoving said proximal tube distally and closer to the distal tube, andthe claw memory metal strips configured to move away from each other bymoving the proximal tube proximally and away from said distal tube.Optionally, the method further includes not altering the shape of theproximal and distal portions while altering the shape of the middleportion. Optionally, the method further includes cooling the proximalportion, the middle portion, and the distal portion after step D) and,after cooling, the proximal and distal portions have substantially thesame size as the proximal and distal portions had prior to step A).Optionally, the method of allowing said middle portion to expandcomprises heating the middle portion. Optionally, the method of alteringthe shape of the middle portion comprises using a mandrel. Optionally,the mandrel is tapered. Optionally, the proximal portion and the distalportion are not cut by the laser. Optionally, prior to cutting thememory metal tube, the memory metal tube has an outer diameter that isfrom about 0.011 inches to about 0.054 inches and an inner diameter thatis from about 0.008 inches to about 0.051 inches.

In an alternate embodiment, the present disclosure provides a system forremoving objects from an interior lumen of an animal that includes:

a pull wire having a proximal end and a distal end;a distal body attached to the pull wire, the distal body comprising aninterior, a proximal end, a distal end, a distal body length extendingfrom the proximal end to the distal end, a proximal hub/junction(preferably in the form of a tube) forming the proximal end of thedistal body, a basket comprised of a plurality of cells formed by aplurality of basket strips, a plurality of proximal strips, and,optionally a distal hub/junction (preferably in the form of a tube)forming a distal end of the basket, the basket comprising a basketinterior, each proximal strip having a proximal end attached to theproximal hub/junction, and a distal end attached to a cell, the distalbody having a relaxed state wherein the distal body has a first heightand a first width, and a collapsed state wherein the distal body has asecond height and a second width, the second height less than the firstheight, the second width less than the first width; anda catheter having an interior, a proximal end leading to the interiorand a distal end leading to the interior, the catheter comprised of abiocompatible material and configured to envelope the distal body whenthe distal body is in the collapsed state,wherein, in the relaxed state, the basket comprises a first pair ofdistal crowns not attached to another cell of the basket and pointinggenerally in the distal direction, the first pair of distal crownslocated approximately the same distance from the proximal hub/junctionand approximately 180 degrees relative to each other (e.g., betweenabout 150 degrees and about 180 degrees relative to each other), andfurther wherein the basket further comprises a second pair of distalcrowns not attached to another cell of the basket and pointing generallyin the distal direction, the second pair of distal crowns locateddistally relative to, and approximately 90 degrees relative to, thefirst pair of distal crowns (e.g., each distal crown of the second pairof distal crowns is located approximately 60 degrees to 90 degreesrelative to a distal crown of the first pair of distal crowns), thedistal crowns in the second pair of distal crowns located approximatelythe same distance from the proximal hub/junction and further whereineach of the distal crowns in the first and second pair of distal crownscomprises an x-ray marker, the x-ray maker more visible under x-ray ascompared to the basket strips when the distal body is located in acranial blood vessel inside the body of a human and the x-ray is takenfrom outside the human's body. Optionally, instead of a distalhub/junction, the basket includes an open distal end.

Optionally, the x-ray markers are comprised of a material different thanthe material forming the basket strips. Optionally, in the relaxedstate, the basket interior is substantially hollow. Optionally, in therelaxed state, the distal body does not have another x-ray marker thatis located approximately the same distance from the proximalhub/junction as the first pair of x-ray markers and the distal body doesnot have another x-ray marker that is located approximately the samedistance from the proximal hub/junction as the second pair of x-raymarkers. In other words, the first and second pair of x-ray markers arethe only markers their respective distances from the proximalhub/junction. Optionally, each distal crown in the first and second pairof distal crowns forms part of an enlarged cell and further wherein thesurface area of each enlarged cell in the relaxed state is greater thanthe surface area of each of the other individual cells of the basket andfurther wherein the enlarged cells are configured to allow a thrombus topass therethrough and into the basket interior. Optionally, in therelaxed state, the distal body does not have another freedistal-pointing crown that is located approximately the same distancefrom the proximal hub/junction as the first pair of distal crowns andthe distal body does not have another free distal-pointing crown that islocated approximately the same distance from the proximal hub/junctionas the second pair of distal crowns. Optionally, the basket strips arecomprised of a memory metal. Optionally, each of the distal crowns inthe first pair and second pair of distal crowns curve radially inwardtoward the basket interior in the relaxed state, wherein the distalcrowns of the first pair of distal crowns are configured to contact eachother when an exterior, external compressive force (such as a thrombus)is exerted on a distal crown of the first pair of distal crowns when thedistal body is in the relaxed state, and further wherein the distalcrowns of the second pair of distal crowns are configured to contacteach other when an exterior, external compressive force (such as athrombus) is exerted on a distal crown of the second pair of distalcrowns when the distal body is in the relaxed state. Optionally, theproximal hub/junction is located approximately in the center of thefirst height and first width in the relaxed state. For example,preferably the proximal hub/junction is located within 0.5 mm of thecenter of first width and the first height. Optionally, the catheter iscomprised of a polymeric material (i.e., one or more polymeric materialssuch as silicone, PVC, latex rubber or braided nylon). Optionally, thepull wire is comprised of a biocompatible metallic material (e.g., abiocompatible metal or a biocompatible metal alloy). Optionally, theproximal end of a first proximal strip is located at least about 65degrees (e.g., between about 65 and about 180 degrees) relative to thedistal end of the first proximal strip, wherein the proximal end of asecond proximal strip is located at least about 65 degrees (e.g.,between about 65 and about 180 degrees) relative to the distal end ofthe second proximal strip, and further wherein the first and secondproximal strips intersect adjacent and distal to the proximalhub/junction (e.g., within about 0 and about 4 mm of the proximalhub/junction). Optionally, each distal crown forms part of a cell thatfurther comprises a proximal crown pointing generally in the proximaldirection and connected to a memory metal strip (e.g., a proximal stripcomprised of a memory metal or a basket strip comprised of a memorymetal). In other words, the proximal crowns are not free. Optionally,the basket, the proximal hub/junction and the proximal strips arecomprised of a memory metal, wherein the proximal hub/junction comprisesa proximal end and a distal end, and further wherein the proximal stripsare integral with the distal end of the proximal hub/junction.Optionally, the length of the distal body from the proximal hub/junctionto the distal hub/junction (not including any lead wire) is from about20 mm to about 65 mm. Optionally, the system is used in a method ofremoving a blood clot from a blood vessel of an animal the methodcomprising the steps of:

a) providing the system;b) positioning the system in the lumen;c) deploying the distal body from the distal end of the catheter;d) allowing the height and width of the distal body to increase;e) irradiating the distal body with x-rays;f) moving the clot into the distal basket interior; andg) moving the distal body proximally out of the blood vessel.

Optionally, the method further comprises irradiating the distal bodywith x-rays at at least two different angles. Optionally, at least onex-ray marker attached to the distal crowns is distal to the clot whenthe distal body is deployed from the distal end of the catheter.Optionally, the method further comprises applying contrast dyeproximally and distally to the clot. Optionally, the method furthercomprises providing a suction catheter having a proximal end and adistal end, and attaching the distal end of the suction catheter to theclot by applying suction to the suction catheter. Optionally, the methodfurther comprises aspirating by hand a pre-determined volume of fluidfrom the suction catheter using a syringe and then locking the syringeat the pre-determined volume. Optionally, the method further comprisesdelivering the suction catheter adjacent to the clot by advancing thecatheter over the pull wire.

In yet another embodiment, the system includes:

a pull wire having a proximal end and a distal end;a distal body attached to the pull wire, the distal body comprising aninterior, a proximal end, a distal end, a distal body length extendingfrom the proximal end to the distal end, a proximal hub/junction(preferably in the form of a tube) forming the proximal end of thedistal body, a basket comprised of a plurality of cells formed by aplurality of basket strips, a plurality of proximal strips, andoptionally a distal hub/junction (preferably in the form of a tube)forming a distal end of the basket, the basket comprising a basketinterior, each proximal strip having a proximal end attached to theproximal hub/junction, and a distal end attached to a cell, the distalbody having a relaxed state wherein the distal body has a first heightand a first width, and a collapsed state wherein the distal body has asecond height and a second width, the second height less than the firstheight, the second width less than the first width; anda catheter having an interior, a proximal end leading to the interiorand a distal end leading to the interior, the catheter comprised of abiocompatible material and configured to envelope the distal body whenthe distal body is in the collapsed state,wherein, in the relaxed state, the basket comprises a first pair ofdistal crowns not attached to another cell of the basket and pointinggenerally in the distal direction, the first pair of distal crownslocated approximately the same distance from the proximal hub/junctionand approximately 180 degrees relative to each other (e.g., betweenabout 150 degrees and about 180 degrees relative to each other), andfurther wherein the basket further comprises a second pair of distalcrowns not attached to another cell of the basket and pointing generallyin the distal direction, the second pair of distal crowns locateddistally relative to, and approximately 90 degrees relative to, thefirst pair of distal crowns (e.g., each distal crown of the second pairof distal crowns is located approximately 60 degrees to 90 degreesrelative to a distal crown of the first pair of distal crowns), thedistal crowns in the second pair of distal crowns located approximatelythe same distance from the proximal hub/junction, wherein each distalcrown of the first and second pair of distal crowns form a cell, eachcell further comprising a proximal crown pointing generally in theproximal direction and connected to a memory metal strip, wherein eachof the distal crowns in the first pair and second pair of distal crownscurve radially inward toward the basket interior in the relaxed state,wherein the distal crowns of the first pair of distal crowns areconfigured to contact each other when an exterior, external compressiveforce (e.g., a thrombus) is exerted on a distal crown of the first pairof distal crowns when the distal body is in the relaxed state, andfurther wherein the distal crowns of the second pair of distal crownsare configured to contact each other when an exterior, externalcompressive force (e.g., a thrombus) is exerted on a distal crown of thesecond pair of distal crowns when the distal body is in the relaxedstate. When it is said that a proximal crown pointing generally in theproximal direction and is connected to a memory metal strip, it is meantthat the proximal crown is either connected to a basket strip or aproximal strip comprised of a memory metal (e.g., nitinol). Optionally,instead of a distal hub/junction, the basket includes an open distalend.

Optionally, the proximal hub/junction is located approximately in thecenter of the first height and first width in the relaxed state. Forexample, preferably the proximal hub/junction is located within 0.5 mmof the center of first width and the first height. Optionally, thecatheter is comprised of a polymeric material (i.e., one or morepolymeric materials such as silicone, PVC, latex rubber or braidednylon). Optionally, the pull wire is comprised of a biocompatiblemetallic material (e.g., a biocompatible metal or a biocompatible metalalloy). Optionally, in the relaxed state, the basket interior issubstantially hollow. Optionally, the proximal end of a first proximalstrip is located at least about 65 degrees (e.g., between about 65 andabout 180 degrees) relative to the distal end of the first proximalstrip, wherein the proximal end of a second proximal strip is located atleast about 65 degrees (e.g., between about 65 and about 180 degrees)relative to the distal end of the second proximal strip, and furtherwherein the first and second proximal strips intersect adjacent anddistal to the proximal hub/junction (e.g., within about 0 mm and about 4mm of the proximal hub/junction). Optionally, each distal crown in thefirst and second pair of distal crowns forms part of an enlarged celland further wherein the surface area of each enlarged cell in therelaxed state is at least twice as large as the surface area of eachother individual cell of the basket and further wherein the enlargedcells are configured to allow a thrombus to pass therethrough and intothe basket interior. Optionally, the pull wire is attached to theproximal hub/junction. Optionally, the basket, the proximal hub/junctionand the proximal strips are comprised of a memory metal, wherein theproximal hub/junction comprises a proximal end and a distal end, andfurther wherein the proximal strips are integral with the distal end ofthe proximal hub/junction. Optionally, the distal body further comprisesa lead wire extending distally from the distal hub/junction, the leadwire having a length of from about 3 mm to about 10 mm. Optionally, thedistal hub/junction, the proximal hub/junction, and the basket arecomprised of a nitinol having the same material composition and furtherwherein the proximal and the distal hubs/junctions are tubular andgenerally cylindrical in shape and each has an outer diameter and aninner diameter, the inner diameter forming apertures of the proximal anddistal hubs/junctions and further wherein the outer diameters of theproximal and distal hubs/junctions are substantially the same size andfurther wherein the inner diameters of the proximal and distalhubs/junctions are substantially the same size. Optionally, the lengthof the distal body from the proximal hub/junction to the distalhub/junction (not including any lead wire) is from about 20 mm to about65 mm.

Optionally, the system is used in a method of removing a blood clot froma blood vessel of an animal the method comprising the steps of:

a) providing the system;b) positioning the system in the lumen;c) deploying the distal body from the distal end of the catheter;d) allowing the height and width of the distal body to increase;e) irradiating the distal body with x-rays;f) moving the clot into the distal basket interior; andg) moving the distal body proximally out of the blood vessel.

Optionally, the method further comprises irradiating the distal bodywith x-rays at at least two different angles.

In still further embodiments, the present disclosure provides yetanother embodiment of a system for removing objects from an interiorlumen of an animal. The system may include a pull wire having a proximalend and a distal end. The system may also include a distal body attachedto the pull wire (e.g., the distal end of the pull wire). The distalbody may include an interior, a perimeter, a proximal end, a distal end,a distal body length extending from the proximal end to the distal end,a proximal junction forming the proximal end of the distal body, aplurality of proximal strips, a basket comprised of a plurality of cellsformed by a plurality of basket strips, and a distal junction forming adistal end of the basket. The basket may include a basket interior. Eachproximal strip may have a distal end attached to a cell and a proximalend, and the proximal ends of the proximal strips may converge at theproximal junction. The distal body may have a relaxed state wherein thedistal body has a first height and a first width, and a collapsed statewherein the distal body has a second height and a second width, thesecond height less than the first height, the second width less than thefirst width. Optionally, in the relaxed state, the basket comprises aseries of at least three pair of cells located on the distal bodyperimeter having a proximal crown pointing generally in the proximaldirection and attached to a memory metal strip and a free distal crownpointing generally in the distal direction. Optionally, in the series,the proximal-most free distal crowns are located at the 12 and 6 o'clockpositions and located about the same distance (i.e., the same distance+/−5 millimeters (mm)) from the proximal junction, the nextproximal-most free distal crowns are located at the 3 and 9 o'clockpositions and located about the same distance (i.e., the same distance+/−5 mm) from the proximal junction, and the succeeding proximal-mostfree distal crowns are located at the 12 and 6 o'clock positions andlocated about the same distance (i.e., the same distance +/−5 mm) fromthe proximal junction. Each free distal crown may form part of adifferent enlarged cell that is configured to allow a thrombus to enterthe basket interior. Optionally, in the relaxed state, the basketcomprises a plurality of distal cells distal to the distal-most freedistal crowns of the series. The plurality of distal cells may have aproximal crown attached to another cell of the basket and pointinggenerally in the proximal direction and a distal crown pointinggenerally in the distal direction and attached to the distal junction.Optionally, each enlarged cell has a proximal end, a distal endcomprising a distal crown pointing generally in the distal direction,and a length extending from the proximal end to the distal end of therespective enlarged cell. Optionally, in the relaxed state, each distalcell has a length extending from the proximal crown to the distal crownof the respective distal cell. Optionally, in the relaxed state, each ofthe enlarged cells is longer than each of the distal cells. Optionally,for some, most or each of the enlarged cells, the distance from theproximal end of the enlarged cell to the free distal crown of theenlarged cell is less than the distance from the free distal crown ofthe enlarged cell to the distal end of the enlarged cell. Optionally, inthe relaxed state, the basket does not have any free crowns that pointgenerally in the proximal direction. Optionally, the distal body, in therelaxed state, comprises a distal tapered region in which the distalbody height and width decrease as the basket approaches the distaljunction. Optionally, each of the enlarged cells is longer than each ofthe pair of cells in the series. Optionally, in the relaxed state, eachof the enlarged cells extends from the 6 o'clock position to the 12o'clock position or the 3 o'clock position to the 9 o'clock position.Optionally, in the relaxed state, the basket further comprises aplurality of proximal cells proximal to the proximal-most free distalcrowns of the series. Optionally, the plurality of proximal cells have aproximal crown attached to the proximal junction and pointing generallyin the proximal direction and a distal crown pointing generally in thedistal direction and attached to another cell of the basket. Optionally,the proximal crowns of the cells comprising the proximal-most freedistal crowns are attached to the distal ends of the proximal strips.Optionally, in the relaxed state, for each of the enlarged cells, twobasket strips meet to form the distal crown located at the distal end ofthe enlarged cell. Optionally, each basket strip has a basket stripproximal end, a basket strip distal end, and a basket strip lengthextending from the proximal end to the distal end. Optionally, for atleast some, most, or each of the enlarged cells, the maximum anglebetween the two basket strips at the same location along the distal bodylength is at least 90 degrees. Optionally, in the relaxed state, forsaid at least some, most or each of the enlarged cells, two basketstrips meet to form the free distal crowns of the enlarged cell, whereineach basket strip has a basket strip proximal end, a basket strip distalend, and a basket strip length extending from the proximal end to thedistal end, and further wherein the maximum angle between the two basketstrips at the same location along the distal body length is no more than40 degrees. Optionally, for at least some, most or each of the enlargedcells, the average angle between the two basket strips is at least 90degrees. Optionally, for at least some, most or each of the enlargedcells, each of the basket strip lengths are approximately equal to ½ ofthe distal body height and width. Optionally, from at least the proximalcrowns of the cells comprising the next proximal-most free distal crownsto the proximal ends of the enlarged cells formed by the succeeding freedistal crowns, the basket has no cells other than the enlarged cells andthe cells comprising the free distal crowns. Optionally, from at leastthe proximal-most free distal crowns to the proximal ends of theenlarged cells formed by the succeeding free distal crowns, the baskethas no cells other than the enlarged cells and the cells comprising thefree distal crowns. Optionally, the distal crowns of the enlarged cellsare attached to another cell of the basket. Optionally, in the relaxedstate, the basket further comprises an additional pair of cells locatedabout the same distance (i.e., the same distance +/−5 mm) from theproximal junction as the cells comprising the proximal-most pair of freedistal crowns and located at the 9 and 3 o'clock positions. Optionally,each cell of the additional pair of cells having a proximal crownattached to a memory metal strip and a distal crown attached to anothercell of the basket. Optionally, the additional pair of cells adjoin theenlarged cells formed by the proximal-most free distal crowns.Optionally, from at least the distal crowns of the additional pair ofcells to the proximal ends of the enlarged cells formed by thesucceeding free distal crowns, the basket has no cells other than theenlarged cells, the cells comprising the free distal crowns and theadditional pair of cells. Optionally, in the relaxed state, the basketcomprises a series of bridge memory metal strips having a proximal endattached to a distal crown of a cell and a distal end attached to aproximal crown of a distally-located cell. Optionally, a proximal pairof bridge memory metal strips are located at the 3 and 9 o'clockpositions. Optionally, a more distally-located pair of bridge memorymetal strips are located at the 12 and 6 o'clock positions. Optionally,each of the pair of bridge memory metal strips forms part of at leastone enlarged cell. Optionally, the bridge memory metal strips are thesole distally-extending basket strips attached to the respectiveproximal crowns and the sole proximally-extending basket strips attachedto the respective distal crowns. Optionally, in the relaxed state, eachof the pair of bridge memory metal strips forms part of two enlargedcells. Optionally, the bridge memory metal strips are substantiallyparallel to the distal body length. Optionally, the plurality of distalcells is comprised of four cells located about the same distance (i.e.,the same distance +/−5 mm) from the proximal junction. Optionally, eachcell has a center, and the centers of the cells are spaced atapproximately 90 degree intervals about the distal body perimeter.Optionally, each of said four cells adjoins two of the other of saidfour cells. Optionally, each of said four cells comprises two lateralcrowns pointing generally in a direction perpendicular to the distalbody length and further wherein each lateral crown of one of said fourcells adjoins a lateral crown of an adjacent one of said four cells.Optionally, the distal body has no more than four cells at any locationalong the distal body length. Optionally, each of the enlarged cells areapproximately the same size. Optionally, in the relaxed state, thebasket interior is substantially hollow. Optionally, the basketcomprises a series of at least five pairs of cells located on the distalbody perimeter having a proximal crown pointing generally in theproximal direction and attached to a memory metal strip and a freedistal crown pointing generally in the distal direction, wherein in theseries, the next proximal-most free distal crowns after the succeedingfree distal crowns are located at the 3 and 9 o'clock positions andlocated about the same distance (the same distance +/−5 mm) from theproximal junction, and the distal-most free distal crowns are located atthe 12 and 6 o'clock positions and located about the same distance (thesame distance +/−5 mm) from the proximal junction. Optionally, theenlarged cells formed by the proximal-most free distal crowns areadjoining, the enlarged cells formed by the next proximal-most freedistal crowns are adjoining and the enlarged cells formed by thesucceeding free distal crowns are adjoining. Optionally, each of theenlarged cells formed by the next proximal-most free distal crownsadjoins an enlarged cell formed by a proximal-most free distal crown andan enlarged cell formed by a succeeding free distal crown. Optionally,the distal body further comprises a lead wire extending distally fromthe distal junction. Optionally, the system further comprises a catheterhaving an interior, a proximal end leading to the interior and a distalend leading to the interior, the catheter comprised of a biocompatiblematerial and configured to envelop the distal body when the distal bodyis in the collapsed state. Optionally, for each enlarged cell, the freedistal crown is aligned with the distal crown located at the distal endof the enlarged cell. Optionally, the distal body, in the relaxed statecomprises a proximal tapered region in which the distal body height andwidth decrease as the proximal strips approach the proximal junction.Optionally, the system is used in a method of removing a blood clot froma blood vessel of an animal that includes: a) providing the system; b)positioning the system in the blood vessel; c) allowing the height andwidth of the distal body to increase; d) moving the blood clot into thebasket interior; and e) moving the distal body proximally out of theblood vessel.

Optionally, instead of three pair of cells in the series, the series mayinclude only two pair of cells located on the distal body perimeterhaving a proximal crown pointing generally in the proximal direction andattached to a memory metal strip and a free distal crown pointinggenerally in the distal direction, and, in the series, the proximal-mostfree distal crowns may be located at the 12 and 6 o'clock positions andlocated about the same distance (the same distance +/−5 mm) from theproximal junction, and the next proximal-most free distal crowns may belocated at the 3 and 9 o'clock positions and located about the samedistance (the same distance +/−5 mm) from the proximal junction. In suchembodiment, the distal body and system may have any feature mentionedabove in connection with the distal body having at least three pairs ofcells with free distal crowns.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a side, elevation view of a memory metal tube priorto being cut by a laser.

FIG. 1B illustrates a side, elevation view of the memory metal tube ofFIG. 1A being cut by a laser.

FIG. 2A illustrates a side, elevation view of the memory metal tube ofFIG. 1B after being cut by a laser; in FIG. 2A, the tube is shown asthough it were flat for purposes of illustrating the cut pattern only.

FIG. 2B illustrates a side, perspective view of the memory metal tube ofFIG. 1B after being cut by a laser.

FIG. 2C illustrates another side, perspective view of the memory metaltube of FIG. 1B after being cut by a laser; in FIG. 2C, the tube isrotated as compared to FIG. 2B.

FIGS. 3A-3H illustrate a method of manufacturing a distal body of oneembodiment of the present invention using the laser cut memory metaltube of FIGS. 1 and 2; in FIGS. 3A-3H, the basket portion of the distalbody is not shown for simplicity of illustration.

FIGS. 4A-4D illustrate the welding steps of the method of manufacturingshown in FIG. 3; in FIGS. 4A-4D, the basket portion of the distal bodyis not shown for simplicity of illustration.

FIGS. 5 and 6 illustrate different locations that connector strips maybe welded to the proximal memory metal strips.

FIG. 7 illustrates a side, elevation view of a catheter and the distalbody of FIG. 6.

FIG. 8 illustrates a side, elevation view of a deployable system of oneembodiment of the present invention being used to capture a blood clot;in FIG. 8, the basket portion of the distal body is not shown forsimplicity of illustration.

FIG. 9 illustrates a side, elevation view of a claw of one embodiment ofthe present invention being closed by a claw actuator tube; in FIG. 9,the basket portion of the distal body is not shown for simplicity ofillustration.

FIG. 10 illustrates a side, elevation view of a deployable system of oneembodiment of the present invention being used to capture a blood clot;in FIG. 10, the basket portion of the distal body is not shown forsimplicity of illustration.

FIG. 11 illustrates a first, perspective view of a distal body of analternate embodiment of the present invention; the distal body is inwhat is referred to herein as “Orientation 1”.

FIG. 12A illustrates a second, perspective view of the distal body ofFIG. 11; the distal body is in what is referred to herein as“Orientation 2”.

FIG. 12B illustrates a proximal, elevation view of the proximal stripsof the distal body of FIG. 11.

FIG. 13 illustrates a close-up, perspective view of two unattacheddistal-pointing crowns of the distal body of FIG. 11.

FIG. 14A illustrates a native memory metal tube used to manufacture thedistal body of FIG. 11; the native tube has been rolled out flat and thelines in the tube indicate where the tube has been cut by a laser.

FIG. 14B illustrates a first, perspective view of the distal bodymanufactured from the native tube of FIG. 14A; the distal body is inOrientation 1.

FIG. 14C illustrates a second, perspective view of the distal bodymanufactured from the native tube of FIG. 14A; the distal body is inOrientation 2.

FIGS. 15A-G illustrate stepwise use of the distal body of FIG. 11 inretrieving a soft clot; the distal body is in Orientation 1.

FIGS. 16A-H illustrate stepwise use of the distal body of FIG. 11 inretrieving a hard clot; the distal body is in Orientation 1.

FIGS. 17A-G illustrate stepwise use of the distal body of FIG. 11 inretrieving a soft clot; the distal body is in Orientation 2.

FIGS. 18A-G illustrate stepwise use of the distal body of FIG. 11 inretrieving a hard clot; the distal body is in Orientation 2.

FIGS. 19A-N illustrate stepwise use of the distal body of FIG. 11 inretrieving a deformable, cohesive adherent clot; the distal body is inOrientation 2.

FIG. 20A illustrates a view of a native memory metal tube used tomanufacture a distal body of yet another embodiment of the presentinvention; the native tube has been rolled out flat, the lines in thetube indicate where the tube has been cut by a laser, and the distalbody of FIGS. 20A-20C is slightly shorter than the distal body of FIGS.11-19 and is meant for use in tortuous blood vessels.

FIG. 20B illustrates a first, perspective view of the distal bodymanufactured from the native tube of FIG. 20A; the distal body is inOrientation 1.

FIG. 20C illustrates a second, perspective view of the distal bodymanufactured from the native tube of FIG. 20A; the distal body is inOrientation 2.

FIG. 21 shows a perspective view of a clot retrieval system thatincludes the distal body of FIGS. 20B-C being delivered in a bloodvessel using a delivery catheter.

FIG. 22 shows a perspective view of the distal body of FIG. 21, afterdeployment of the distal body and retraction of the delivery catheter,in a blood vessel.

FIG. 23 shows a perspective view of the distal body of FIG. 21; ascompared to FIG. 22, the distal body has been moved proximally andtension has been exerted on the pull wire.

FIG. 24 shows a perspective view of a suction catheter that is beingdelivered over the pull wire of the system of FIG. 21.

FIG. 25 shows a perspective view of the distal end of the suctioncatheter of FIG. 24 being pushed into a clot; a syringe is sucking theclot to the suction catheter because the user has pulled back on thelever of the syringe.

FIG. 26 shows a perspective view of the distal end of the suctioncatheter of FIG. 24 being pushed into a clot; in FIG. 26, the user haslocked the syringe lever at the desired volume.

FIG. 27 shows a perspective view of the system of FIG. 24; in FIG. 27,the suction catheter has partially sucked the distal body and clot intothe suction catheter.

FIG. 28 shows a perspective view of the system of FIG. 24; in FIG. 28,the suction catheter has completely sucked the distal body and clot intothe suction catheter.

FIG. 29 shows a perspective view of the system of FIG. 24; the system,and captured clot, is being removed proximally from the vessel.

FIG. 30 illustrates a right side perspective view of a mandrel used toprepare unattached distal-pointing crowns that curve radially toward thebasket interior.

FIG. 31 illustrates a right side elevation view of the mandrel of FIG.30.

FIG. 32 illustrates an alternate embodiment of a distal body; in thedistal body of FIG. 32, the proximal strips converge and are soldered orwelded at the proximal hub/junction and the basket strips located at thedistal end of the basket converge and are soldered or welded at thedistal hub/junction.

FIG. 33A illustrates a native memory metal tube used to manufacture adistal body of another embodiment of the present invention; the nativetube has been rolled out flat and the lines in the tube indicate wherethe tube has been cut by a laser.

FIG. 33B illustrates a first, perspective view of the distal bodymanufactured from the native tube of FIG. 33A; in FIG. 33B, the distalbody is in Orientation 1.

FIG. 33C illustrates a second, perspective view of the distal bodymanufactured from the native tube of FIG. 33A; in FIG. 33C, the distalbody is in Orientation 2.

FIG. 34A illustrates a first, perspective view of a distal body ofanother embodiment of the present invention; in FIG. 34A, the distalbody is in Orientation 1.

FIG. 34B illustrates a second, perspective view of the distal body ofFIG. 34A; in FIG. 34B, the distal body is in Orientation 2.

FIG. 35A illustrates a first, perspective view of a proximal portion ofa distal body of another embodiment of the present invention; in FIG.35A, the distal body is in Orientation 1.

FIG. 35B illustrates a second, perspective view of the proximal portionof the distal body of FIG. 35A; in FIG. 35B, the distal body is inOrientation 2.

FIG. 36A illustrates a front perspective view of a distal body ofanother embodiment of the present invention; in FIG. 36A, the distalbody is in the relaxed state.

FIG. 36B illustrates another front perspective view of the distal bodyof FIG. 36A without the proximal and distal hubs/junctions and pullwire.

FIG. 36C illustrates an enlarged front perspective view of the distalbody of FIG. 36A.

FIG. 36D illustrates an enlarged front perspective view of the arealabelled 36D in FIG. 36C.

FIG. 36E illustrates an enlarged front perspective view of the arealabelled 36E in FIG. 36C.

FIG. 36F illustrates an enlarged front perspective view of the arealabelled 36F in FIG. 36C.

FIG. 36G illustrates an enlarged front perspective view of the arealabelled 36G in FIG. 36E.

FIG. 36H illustrates an enlarged front perspective view of the arealabelled 36H in FIG. 36F.

FIG. 36I illustrates a top plan view of the distal body of FIG. 36A.

FIG. 36J illustrates a front elevation view of the distal body of FIG.36A.

FIG. 36K illustrates a bottom plan view of the distal body of FIG. 36A.

FIG. 36L illustrates a rear elevation view of the distal body of FIG.36A.

FIG. 36M illustrates a proximal elevation view of the distal body ofFIG. 36A; in FIG. 36M, the miniature clock faces illustrate the 12, 3, 6and 9 o'clock positions.

FIG. 36N illustrates a distal elevation view of the distal body of FIG.36A; in FIG. 36N, the miniature clock faces illustrate the 12, 3, 6 and9 o'clock positions.

FIG. 37A illustrates a front perspective view of a distal body ofanother embodiment of the present invention; in FIG. 37A, the distalbody is in the relaxed state.

FIG. 37B illustrates another front perspective view of the distal bodyof FIG. 37A without the proximal and distal hubs/junctions and pullwire.

FIG. 37C illustrates a top plan view of the distal body of FIG. 37A.

FIG. 37D illustrates a front elevation view of the distal body of FIG.37A.

FIG. 37E illustrates a bottom plan view of the distal body of FIG. 37A.

FIG. 37F illustrates a rear elevation view of the distal body of FIG.37A.

FIG. 37G illustrates an enlarged front elevation view of the arealabelled 37G in FIG. 37A.

FIG. 37H illustrates a proximal elevation view of the distal body ofFIG. 37A; in FIG. 37H, the miniature clock faces illustrate the 12, 3, 6and 9 o'clock positions.

FIG. 37I illustrates a distal elevation view of the distal body of FIG.37A; in FIG. 371, the miniature clock faces illustrate the 12, 3, 6 and9 o'clock positions.

FIG. 37J illustrates an enlarged front perspective view of the arealabelled 37J in FIG. 37A.

FIG. 37K illustrates an enlarged rear elevation view of the arealabelled 37K in FIG. 37F.

DETAILED DESCRIPTION

With reference to FIGS. 1-10, the present disclosure provides adeployable system, generally designated by the numeral 10, for removingan obstruction such as a blood clot 12 or other object from a bloodvessel 14 or other interior lumen of an animal. In addition to a bloodclot 12, the obstruction may be, for example, extruded coils duringaneurysm treatment, intravascular embolic material such as onyx or otherobstructions requiring mechanical intravascular removal from smalldistal vessels. In the drawings, not all reference numbers are includedin each drawing for the sake of clarity.

Referring further to FIGS. 1-10, the deployable system 10 includes apull wire 16 that has a proximal end (not shown) and a distal end 20.Optionally, the diameter of the pull wire is between about 0.008 inchesand about 0.051 inches. Preferably, the pull wire 16 is comprised of abiocompatible metallic material.

The system 10 further includes a distal body 22, which is attached tothe pull wire 16. The distal body 22 has a proximal end 24, a distal end26, an interior 28, and an exterior 30. The distal body 22 has acollapsed state, wherein the distal body 22 has a first height and widthand is configured to fit into a catheter 50 (see FIG. 10A), and arelaxed state wherein the distal body 22 has a different height 32 andwidth and is configured to expand to about the height and width of ahuman blood vessel 14 when the distal body 22 is deployed from thecatheter 50 (see FIGS. 10B-G). The distal body 22 further includes aproximal hub/junction 74 and a distal hub/junction 76 that is locateddistal relative to the proximal hub/junction 74. In some embodiments,the distal body 22 includes a plurality of strips 40 comprised of amemory metal (e.g., a memory metal alloy such as nitinol) that form theproximal end 24 of the distal body 22. Optionally, the proximal memorymetal strips 40 each have a distal end 44 and a proximal end 42 thatforms an openable and closeable claw 46. Optionally, the proximal memorymetal strips 40 are attached to the proximal hub/junction 74 throughconnector memory metal strips 48. In such embodiments, the proximalhub/junction 74 may be slideable along at least a segment of the pullwire 16, in contrast to the distal hub/junction 76, which is optionallyfixed to the pull wire 16 and not slideable along the pull wire 16.Moving the proximal hub/junction 74 distally and closer to the distalhub/junction 76 (i.e., shortening the distance 88 between the proximalhub/junction 74 and distal hub/junction 76 by moving the proximalhub/junction 74 distally while keeping the distal hub/junction 76stationary) exerts tension on the connector memory metal strips 48 and,in turn, the proximal memory metal strips 40. This tension, in turn,causes the proximal ends 42 of the proximal memory metal strips 40 tomove radially toward each other and the pull wire 16. As the proximalends 42 of the proximal memory metal strips 40 move radially toward eachother and the pull wire 16, the claw 46 (formed by the proximal memorymetal strips 40) is brought from the open position to at least apartially closed position, which in turn, separates the obstruction 12from the wall of the human lumen 14 and captures the obstruction 12. SeeFIG. 3H, FIG. 8, FIG. 9F, and FIG. 10F and 10G. Conversely, preferably,movement of the proximal hub/junction 74 proximally and away from thedistal hub/junction 76 (i.e., increasing the distance 88 between thehubs/junctions 74 and 76) releases the tension in the proximal memorymetal strips 40, which in turn, causes the proximal ends 42 of theproximal memory metal strips 40 to move away from each other and thepull wire 16, opening the claw 46. The claw 46 and proximal hub/junction74 form several functions. First, as described, closing of the claw 46captures the obstruction 12. Second, closing the claw 46 retracts theclaw 46 from the wall of the lumen 14 so that the claw 46 does notscrape against (and damage) the lumen wall while capturing theobstruction 12. Third, closing the claw 46 reduces the height and widthof the distal body 22, which allows the distal body 22 to be re-sheathedin the catheter 50, which may be desired, for example, if the operatorseeks to re-deploy the distal body 22 in another location in the body(which may be the case if the operator originally deploys the distalbody 22 in the wrong location in the lumen 14). For purposes of thepresent invention, “closing the claw” embraces both partially closingthe claw 46 (where the proximal ends 42 of the proximal memory metalstrips 40 do not contact the pull wire 16) and fully closing the claw 46(where the proximal ends 42 contact the pull wire 16).

The claw 46 may be comprised of any number of proximal memory metalstrips 40. Preferably, however, between 2 and 4 proximal memory metalstrips 40 comprise the claw 46 (it being understood that the connectorstrips 48, if present, merely serve to tether the claw 46 to theproximal hub/junction 74). Preferably, the proximal memory metal strips40 have a length of between about 10 and about 60 millimeters. Theproximal memory metal strips 40 can be thought of as arms of the claw46.

In some embodiments, the connector strips 48 are integral with theproximal hub/junction 74 (i.e., formed from the same piece of memorymetal). In other embodiments, the proximal hub/junction 74 may be weldedor soldered to the connector strips 48. Optionally, in the relaxedstate, the proximal memory metal strips 42 are distributed substantiallyevenly about a perimeter of the distal body 22.

Optionally, the distal body 22 includes a lead wire 52 extendingdistally from the distal body 22. Optionally, the lead wire 52 extendsdistally from the distal hub/junction 76. If present, the lead wire 52may be used to facilitate movement of the system 10 in the lumen 14.

Optionally, the distal body 22 includes a basket 54 distal to theproximal memory metal strips 40, the basket 54 comprised of a pluralityof memory metal strips 56 distal relative to the proximal memory metalstrips 40. The distal memory metal strips 56 may, for example, form abasket 54 with a plurality of mesh openings 58. Optionally, the size ofthe mesh openings 58 in the basket 54 when the distal body 22 is in itsrelaxed state is less (preferably significantly less) than the diameterof an average-sized ischemic blood clot 12 so that the blood clot 12does not escape from the distal basket 54 after being captured by thedistal body 22. Optionally, the basket 54 has an open proximal end 60and a substantially closed distal end 62, which is formed by distal tube76. Optionally, the distal and proximal hubs/junctions 74 and 76 and thedistal basket 54 are comprised of a nitinol having the same materialcomposition. Optionally, the size of the mesh openings 58 decreases fromthe proximal end 60 of the basket 54 to the distal end 62. The distalbasket 54 is best seen in FIG. 2 and can be comprised of a differentnumber of cell patterns. The distal basket 54 is not shown in FIGS. 3-10for ease of illustrating the other components in the system 10.

Optionally, the proximal hub/junction 74 and the distal hub/junction 76are cylindrical tubes comprising substantially circular apertures thatspan the length of the hubs/junctions 74 and 76 and the hubs/junctions74 and 76 have approximately the same inner diameter 72 and the sameouter diameter 70. Preferably, the inner diameter 72 is at leastslightly larger than the diameter of the pull wire 16 so that the pullwire 16 can slide through the proximal hub/junction 74. In someembodiments, the outer diameters 70 of the proximal and distalhubs/junctions 74 and 76 may be from about 0.011 inches to about 0.054inches and the inner diameters 72 of the proximal and distalhubs/junctions 74 and 76 may be from about 0.008 inches to about 0.051inches.

Optionally, the distal body 22 further comprises an x-ray marker 64 thatis more visible under x-ray as compared to the proximal memory metalstrips 40 when the distal body 22 is located in a cranial blood vesselinside the body of a human and the x-ray is taken from outside thehuman's body. If the connector strips 48 are welded or soldered to theproximal memory metal strips 40, the x-ray markers 64 may be, forexample, located at the welding or soldering site. In some cases, theincreased thickness at the welding or soldering site may in of itselfcomprise the x-ray marker 64. Preferably, the x-ray marker 64 iscomprised of a radiopaque material. Some examples of radiopaquematerials can include, but are not limited to, gold, platinum,palladium, tantalum, tungsten alloy, polymer material loaded withradiopaque filler, and the like. Preferably, the proximal memory metalstrips 40 are comprised of nitinol and the x-ray marker 64 is comprisedof a material having a density greater than the nitinol.

A catheter 50 with an open proximal end (not shown) and an open distalend 66 initially envelopes the system 10. As used herein, the term“catheter” generally refers to any suitable tube through which thesystem 10 can be deployed. Preferably, the catheter 50 is sterile andcomprised of a biocompatible material (i.e., a material that does notirritate the human body during the course of a 45 minute operation thatinvolves using the system 10 to remove a clot 12 from an intracranialblood vessel 14). The catheter 50 can be any suitable shape, includingbut not limited to generally cylindrical. Preferably, the catheter 50 isa microcatheter. For purposes of the present invention, when it is saidthat the catheter 50 envelopes the system 10, it will be understood thatthe catheter 50 envelopes at least one component of the system 10(preferably, the distal body 22, the lead wire 52, and the pull wire16). In some embodiments, the catheter 50 is about 2.5 French indiameter. Optionally, the catheter 50 is delivered to the region of thelumen 14 that has the obstruction 12 as follows: a guide wire isdelivered to the obstruction region past the obstruction 12; thecatheter 50 is delivered over the guide wire; the guide wire is removed;and the system 10 is delivered with its pull wire 16 and lead wire 52through the catheter 50. Optionally, the pull wire 16 is used to pushthe system 10 through the catheter 50 as well as to retrieve the distalbody 22 after capturing the obstruction 14 as described below. Thesystem 10 may utilize a plurality of catheters 50, such as, for example,a wider catheter that travels to the brain and a very flexible, smallerdiameter microcatheter that is delivered from the first catheter andtravels through the small arteries of the brain. Preferably, thecatheter 50 is comprised of a biocompatible, polymeric material (i.e.,one or more polymeric materials such as silicone, PVC, latex rubber orbraided nylon).

Optionally, in the relaxed, opened-claw state, the distal body 22 oroptionally just the distal basket 54 has a tapered shape (e.g.,substantially conical or bullet in shape) so that the distal body 22 orjust the distal basket 54 tapers from the distal body 22 or the distalbasket's 54 proximal end to the distal end.

The proximal end of the system 10 is shown at the left end of FIGS. 1and 3-10 and the distal end of the system 10 is shown at the right endof FIGS. 1 and 3-10 because a principal use of the system 10 is toremove a blood clot 12 from a human intracranial artery 14, in whichcase the system 10 generally will enter the artery 14 at its proximalend by the surgeon entering the patient's body near the groin andpushing the catheter 50 towards the brain. The diameter of humanarteries 14 generally decrease from their proximal end to their distalend. However, when used in other types of lumens, the distal body 22 maybe located proximally relative to the catheter 50 as the term proximallyand distally are used in that lumen.

The surgeon may deploy the distal body 22 by, for example, moving thecatheter 50 proximally so as to unsheathe the distal body 22 or bypushing the distal body 22 out of the catheter 50.

Use of the system 10 will now be described to remove a blood clot 12from an intracranial artery 14 of a human ischemic stroke patient,however, it will be appreciated that the system 10 may be used to removeother objects from other interior lumens.

A catheter 50, which contains the collapsed distal body 22 is positionedin the lumen 14 distal to the clot 12. See FIG. 10A.

The distal body 22 is deployed from the catheter 50 and the height andwidth of the distal body 22 expand to about the height and width of theblood vessel 14. See FIG. 10B.

The catheter 50 is pulled proximally and a claw-actuator tube 90 isdeployed into the blood vessel 14. See FIG. 10C.

The distal body 22 is moved proximally so that the clot 12 is located inthe interior 28 of the distal body 22. See FIGS. 10D and 10E.

The claw-actuator tube 90 is moved distally, which pushes the proximalhub/junction 74 distally so that the distance 88 between the proximalhub/junction 74 and the distal hub/junction 76 (which is fixed to thepull wire 16 and kept stationary) decreases. Distal movement of theproximal hub/junction 74 exerts tension on the connector and proximalmemory metal strips 40 and 48, which in turn, closes the claw 46. SeeFIG. 10F. (The claw actuator tube 90 should float on the pull wire16—i.e., have an aperture extending the tube's length that has adiameter larger than the diameter of the pull wire 16—and the apertureof the claw actuator tube 90 should be smaller than the diameter of theproximal hub/junction 74 so that the claw actuator tube 90 pushes theproximal hub/junction 74).

The system 10 is withdrawn proximally and removed from the body. SeeFIG. 10G.

To test the efficacy of the system 10, a distal body 22 with a distalbasket 54, proximal and distal hubs/junctions 74 and 76, and a claw 46comprised of three proximal memory metal strips 42 was tested in a flowmodel that included a tube and a moist cotton ball located in the tube.The cotton ball was used to simulate a blood clot. The system 10 wasdeployed distal to the cotton ball. The claw 46 was closed by moving theproximal hub/junction 74 distally to capture the cotton ball. The system10 and cotton ball were withdrawn proximally in the tube.

In some embodiments, the distal body 22 is prepared by a process thatincludes one or more of the following steps, as illustrated in FIGS. 1-4

a) providing a single tube 68 comprised of a memory metal such asnitinol, the single tube 68 having an exterior, a substantially hollowinterior, a wall separating the exterior from the substantially hollowinterior, an open proximal end 74, an open distal end 76, a middleportion 78 between the open proximal end 74 and the open distal end 76(see FIG. 1A);b) cutting the wall of the middle portion 78 with a laser 80 (see FIG.1B);c) removing the pieces of the middle portion 78 cut by the laser 80 toform a proximal tube 74, a distal tube 76 and a middle portion 78comprising a plurality of memory metal strips 82 attached to theproximal tube 74;d) altering the shape of the middle portion 78 using a mandrel andallowing the middle portion 78 to expand relative to the distal tube 76and proximal tube 74 to form the distal basket 54;e) quenching the middle portion 78 at room temperature;f) removing the mandrel from the middle portion 78 (see FIGS. 2 and 3A);g) mechanically or chemically electropolishing the middle portion 78 toremove oxides;h) cutting the memory metal strips 82 to form a first segment 84comprising the proximal tube 74 and a proximal segment of the memorymetal strips 82 and a second segment 86 comprising the distal tube 76and a distal segment of the memory metal strips 82 (see FIG. 3B); andi) joining the proximal segments to the distal segments such that thedistal segments form the proximal end 24 of the distal body 22, suchthat the proximal tube 74 is located inside the interior 28 of thedistal body 22, and such the proximal tube 74 is located distal relativeto the distal body proximal end 24 (see FIGS. 3C-3E).

In some embodiments, the method further includes placing the pull wire16 through the proximal tube 74 so that the proximal tube 74 isslideable along at least a segment of the pull wire 16.

In some embodiments, the method further includes attaching the pull wire16 to the distal tube 76 so that the distal tube 76 is not slideablealong the pull wire 16 but instead the distal tube 76 moves with thepull wire 16.

In some embodiments, after step i, the proximal end 24 of the distalbody 22 forms a claw 46 comprised of between 2 to 4 proximal memorymetal strips 40, the claw proximal memory metal strips 40 configured tomove towards each other and the pull wire 16 by moving the proximal tube74 distally and toward the distal tube 76 (i.e., decreasing the distance88 between the tubes 74 and 76) and the claw memory metal strips 40configured to move away from each other and away from the pull wire(i.e., increasing the distance 88 between the tubes 74 and 76) by movingthe proximal tube 76 proximally and away from the distal tube 76 (asdescribed previously).

In some embodiments, the middle portion 78 is expanded by heating themandrel and the middle portion 78 by, for example, placing the mandreland the middle portion 78 in a fluidized sand bath at about 500° C. forabout 3 to about 7 minutes. As the middle portion 78 is heated, theheating causes the crystalline structure of the memory metal tube 68 torealign. Preferably, the mandrel is tapered (e.g., substantially conicalor bullet in shape) so that the distal basket 54 formed from the middleportion 78 tapers from the proximal end 60 to the distal end 62.Preferably, the proximal and distal ends of the tube 74 and 76 are notshape set by the mandrel and are not cut by the laser 80 so that theproximal and distal ends 74 and 76 do not change in shape and onlyslightly expand in size under heating and return to the size of thenative tube 68 after the heat is removed. Preferably, the laser cuts areprogrammed via a computer. To ensure that the laser cuts only onesurface of the tube wall at the time (and not the surface directlyopposite the desired cutting surface), the laser 80 is preferablyfocused between the inner and outer diameter of the desired cuttingsurface and a coolant is passed through the memory metal tube 68 so thatthe laser 80 cools before reaching the surface directly opposite thedesired cutting surface.

The portions of the wall not cut by the laser 80 create the distalbasket 53, proximal and distal tubes 74 and 76, and memory metal strips40, 48 and 56, as described.

Preferably, the memory metal selected for the native tube 68 has a heatof transformation below average human body temperature (37° C.) so thatthe distal body 22 has sufficient spring and flexibility afterdeployment from the catheter 50 in the human blood vessel 14.

In some embodiments, the native tube 68 (and hence the distal andproximal tubes 74 and 76) have an outer diameter of less than about 4French, e.g., a diameter of about 1 to about 4 French. In someembodiments, the diameter of the pull wire 16 is between about 0.008inches and about 0.051, as noted above, and in such embodiments, thediameter of the pull wire 16 may be approximately equal to the innerdiameter 72 of the native nitinol tube 68.

Without being bound by any particular theory, it is believed thatmanufacturing the distal body 22 from a single memory metal tube 68provides ease of manufacturing and safety from mechanical failure andprovides tensile strength necessary for the system 10 to remove hardthrombus 12 and other obstructions.

The Embodiments of FIGS. 11-29

FIGS. 11-29 illustrate an alternate embodiment 200 that includes one ormore of the following additional features, as described below: twistingproximal strips/tethers 252, unattached/free distal-pointing crowns 258that optionally curve inward and have x-ray markers 244, and enlargedopenings/drop zones 262 in the basket 246 immediately distal to theunattached, distal-pointing crowns 258 that allow the obstruction orother object 270 to enter the distal basket interior 222.

More specifically, as shown in FIGS. 11-29, the system 200 may include apull wire 202 having a proximal end 204 and a distal end 206, asdescribed above, a distal body 216 attached to the pull wire 202, thedistal body 216 comprising an interior 222, a proximal end 218, a distalend 220, a distal body length 226 extending from the proximal end 218 tothe distal end 220, a distal body height 224, a proximal hub/junction228 (preferably in the form of a tube and which has a proximal end 230and a distal end 232) forming the proximal end 218 of the distal body216, a basket 246 comprised of a plurality of cells/openings 248 formedby a plurality of basket strips 291 that preferably are comprised of amemory metal, optionally a distal hub/junction 236 that forms the distalend of the basket 246 (preferably in the form of a tube that has aproximal end 238 and a distal end 240), and a plurality of proximalstrips 252 (preferably the proximal strips 252 are comprised of a memorymetal), each proximal strip 252 having a proximal end 254 attached tothe proximal hub/junction/tube 228, and a distal end 256 attached to acell 248 (more specifically a proximal-pointing crown of a cell 248located at the proximal end of the basket 246), the basket comprising abasket interior 292, the distal body 216 having a relaxed state whereinthe distal body 216 has a first height and width, a collapsed statewherein the distal body 216 has a second height and width, the secondheight less than the first height, the second width less than the firstwidth; and a delivery catheter 208 for delivering the distal body 216,as described above, having an interior 210, a proximal end 212 leadingto the interior 210 and a distal end 214 leading to the interior 210,the delivery catheter 208 comprised of a biocompatible (preferablypolymeric) material and configured to envelope the distal body 216 whenthe distal body 216 is in the collapsed state. Optionally, the basketinterior 292 is substantially hollow—i.e., unlike U.S. PatentPublication No. 2013/0345739, the basket interior 292 does not containan inner elongate body. Optionally, instead of a distal hub/junction236, the basket 246 includes an open distal end. Optionally, at leasttwo cells 250 of the basket 246 comprise a proximal crown 260 pointinggenerally in the proximal direction and a distal crown 258 pointinggenerally in the distal direction, and the distal crowns 258 of the atleast two cells 250 are not attached to another cell 248 of the basket246. In other words, the distal crowns 258 of at least two cells 250 arefree floating and are not attached to any strip except for the stripsforming part of the at least two cells 250; such distal crowns 258 arereferred to below as unattached, distal-pointing crowns 258. Preferably,the distal tips of the unattached, distal-pointing crowns 258 terminateat an x-ray marker 244. (Cells labeled with the numerals 250, 250A,250B, 250C, and 250D refer to the at least two cells that include aproximal crown 260 pointing generally in the proximal direction and anunattached, distal-pointing crown 258, cells labeled with the numerals262, 262A, 262B, 262C, and 262D refer to the enlarged cells/drop zonesadjacent to (preferably immediately distal to) an unattached,distal-pointing crown 258, and cells designated with numeral 248 referto generally the cells of the basket 246). (When it is said that theenlarged cells/drop zones 262 are preferably immediately distal to anunattached, distal-pointing crown 258, it will be understood that atleast a portion of an enlarged cell/drop zone 262 is immediately distalto an unattached, distal-pointing crown 258, and that a portion of theenlarged cell/drop zone 262 may be proximal to an unattached,distal-pointing crown 258, as shown in FIGS. 11-12 due to the shape ofthe enlarged cells/drop zones 262). It will be understood that partnumber 250 refers generally to one or more of the at least two cells,whereas part numbers 250A, 250B, 250C, and 250D refer to a specific oneof the at least two cells. Similarly, it will be understood that partnumber 262 refers generally to one or more of the enlarged cells/dropzones, whereas part numbers 262A, 262B, 262C, and 262D refer to aspecific one of the enlarged cells/drop zones. Similarly, it will beunderstood that part number 258 refers generally to one or more of theunattached, distal-pointing crowns, whereas part numbers 258A, 258B,258C, and 258D refer to a specific one of the unattached,distal-pointing crowns.

Optionally, at least two of the unattached, distal-pointing crowns 258are located approximately 180 degrees (e.g., about 150 to about 180degrees) relative to each other and approximately the same distance fromthe proximal hub/junction/tube 228, as best seen in FIG. 12A.Optionally, the basket 246 comprises a first pair of unattached,distal-pointing crowns 258A and 258B, each of the first pair ofunattached, distal-pointing crowns 258A and 258B is locatedapproximately the same distance from the proximal hub/junction/tube 228and approximately 180 degrees relative to each other, and the basket 246further comprises a second pair of unattached, distal-pointing crowns258C and 258D located distally relative to, and approximately 90 degrees(e.g., between about 60 and about 90 degrees) relative to, the firstpair of unattached, distal-pointing crowns 258A and 258B. Optionally,the second pair of unattached, distal-pointing crowns 258C and 258D formcells 250C and 250D that are adjacent to, but offset from, the cells250A and 250B formed by the first pair of unattached, distal-pointingcrowns 258A and 258B. (In other words, optionally, the center of cell250A is about 90 degrees relative to the centers of cells 250C and 250Dand optionally the center of cell 250B is also about 90 degrees relativeto the centers of cells 250C and 250D). Optionally, at least one of (andpreferably all) the unattached, distal-pointing crowns 258A, 258B, 258Cor 258D comprise an x-ray marker 244 that is more visible under x-ray ascompared to the basket strips 291 when the distal body 216 is located ina cranial blood vessel 266 inside the body of a human and the x-ray istaken from outside the human's body. Preferably, the x-ray marker 244 isa radiopaque material. Some examples of radiopaque materials caninclude, but are not limited to, gold, platinum, palladium, tantalum,tungsten alloy, polymer material loaded with radiopaque filler, and thelike. Preferably, the basket strips 291 are comprised of nitinol and thex-ray marker 244 is comprised of a material having a density greaterthan the nitinol. In some embodiments, the x-ray markers 244 comprise aheavy metal welded or soldered to the unattached, distal-pointing crowns258. Optionally, the unattached, distal-pointing crowns 258 curve subtlytowards the interior 222 of the distal basket 246, which decreases thelikelihood that the unattached, distal-pointing crowns 258 will rubagainst and damage the vessel wall 268. Optionally, the basket 246comprises at least two cells proximal to the at least two cells 250 thatinclude the unattached, distal-pointing crowns 258. Optionally, theunattached, distal-pointing distal crowns 258 are located about at least5 mm (e.g., about 5 to about 30 mm) from the proximal hub/junction/tube228. Optionally, the unattached, distal-pointing crowns 258 are locatedat least about 5 mm from the distal hub/junction/tube 236. Optionally,the unattached, distal-pointing crowns 258 of the at least two cells 250also each form part (namely a portion of the proximal boundary) of anenlarged cell 262 (which is the entry point of hard thrombus 270B intothe basket interior 222) and further wherein the surface area of theenlarged cells 262 in the relaxed state is greater than the surface areaof the other cells of the basket 246 in the relaxed state. Optionally,the unattached, distal-pointing crowns 258 serve several functions: 1)they form flex points of the basket 246, which makes it easier for thesystem 200 to navigate the curves of the blood vessels 266 of thebrains; 2) through the use of x-ray markers 244 on the unattached,distal-pointing crowns 258, they allow the operator to locate theenlarged cells 262 of the basket 246 that form the point at which hardthrombuses 270B enter the basket 246; and 3) they allow the operator toratchet or force the object 270 into the basket 246 by moving theunattached, distal-pointing crowns 258 proximally and distally relativeto the object 270. (As explained below, the numeral 270 refers toclots/thrombuses and other objects generally, and 270A refers to a softclot, 270B refers to a hard clot and 270C refers to a deformable,cohesive, adherent clot). Optionally, the proximal end 254 of a proximalstrip 252 is located about 65-180 degrees (preferably approximately 180degrees) relative to the distal end 256 of the same proximal strip 252,as best seen in FIG. 12B. In other words, preferably the proximal end254 of a first proximal strip 252 is attached to the 12 o'clock positionon the proximal tube 228 and the distal end 256 of the first proximalstrip 252 (which terminates at a proximal cell 248 of the basket 246) islocated at the 6 o'clock position (i.e., 180 degrees from the startposition), and the proximal end 254 of a second proximal strip 252 isattached to the 6 o'clock position on the proximal tube 228 and thedistal end 254 (which terminates at a cell 248 of the basket 246) of thesecond proximal strip 252 is located at the 12 o'clock position (i.e.,180 degrees from the start position). This twisting feature serves twofunctions: 1) it allows the proximal strips 252 to surround the object270; and 2) it allows the manufacturer to insert a mandrel into thebasket 246 during the shape-setting procedure. Optionally, the pull wire202 is attached to the proximal tube 228 (e.g., by gluing, welding,soldering or the like). Preferably, the pull wire 202 does not extendthrough the distal basket interior 222. Optionally, the proximal strips252 are integral with the distal end 232 of the proximal tube 228 andthe entire distal body 216 is created from a single tube 264 of a memorymetal. Optionally, the proximal crowns 260 of the at least two cells 250that include the unattached, distal pointing-crowns 258 are eachattached to another cell 248 of the basket 246. In other words,preferably the basket 246 does not have any free-floatingproximal-pointing crowns, as free-floating proximal-pointing crownscould damage the vessel 266 when the distal body 216 is pulledproximally. Optionally, the system 200 further comprises a lead wire 286extending distally from the distal tube 236, the lead wire 286 having alength of from about 3 mm to about 10 mm. Optionally, the distalhub/junction/tube 236, the proximal hub/junction/tube 228, and thebasket 246 are comprised of a nitinol having the same materialcomposition. In other words, as with the prior embodiment of FIGS. 1-10,optionally the entire distal body 216 is manufactured from a single tubeof nitinol 264. Optionally, the proximal and distal hubs/junctions/tubes228 and 236 comprise an x-ray marker 244 that is more visible underx-ray as compared to the basket strips 291 when the distal body 216 islocated in a cranial blood vessel 266 inside the body of a human and thex-ray is taken from outside the human's body. Preferably, the x-raymarker 244 is a radiopaque material. Some examples of radiopaquematerials can include, but are not limited to, gold, platinum,palladium, tantalum, tungsten alloy, polymer material loaded withradiopaque filler, and the like. Preferably, the basket strips 291 arecomprised of nitinol and the x-ray marker 244 is comprised of a materialhaving a density greater than the nitinol. In some embodiments, theproximal and distal hubs/junctions/tube interiors 234 and 242 maycomprise tantalum welded or otherwise attached to the interior 234 and242 of the proximal and distal hubs/junctions/tubes 228 and 236.Optionally, the proximal and the distal tubes 228 and 236 are generallycylindrical in shape and each has an outer diameter and an innerdiameter, the inner diameter forming apertures of the proximal anddistal tubes 228 and 236 and further wherein the outer diameters of theproximal and distal tubes 228 and 236 are substantially the same sizeand further wherein the inner diameters of the proximal and distal tubes228 and 236 are substantially the same size. Optionally, the outerdiameters of the proximal and distal tubes 228 and 236 are from about0.011 inches to about 0.054 inches, and further wherein the innerdiameters of the proximal and distal tubes 228 and 236 are from about0.008 inches to about 0.051 inches. Optionally, the pull wire 202 isgenerally cylindrical and further wherein the diameter of the pull wire202 is between about 0.008 inches and about 0.051 inches. Optionally,the distal body 216 has a length of between about 10 and about 60millimeters. Optionally, the first height 224 and first width 226 of thedistal body 216 are between about 2 millimeters and about 6 millimeters.

The present disclosure also provides a method of removing a clot orother object 270 from an interior lumen 266 of an animal, the methodcomprising the steps of:

a) providing the system 200 of FIGS. 11-29, wherein at least two cells250 of the basket 246 comprise a proximal crown 260 pointing generallyin the proximal direction and a distal crown 258 pointing generally inthe distal direction, and the distal crowns 258 of the at least twocells 250 are not attached to another cell 248 of the basket 246 (i.e.,free-floating), and further wherein at least one of the unattached,distal-pointing crowns 258 comprises an x-ray marker 244;

b) positioning the system 200 in the lumen 266;

c) deploying the distal body 216 from the distal end 214 of the deliverycatheter 208;

d) allowing the height and width 224 and 226 of the distal body 216 toincrease;

e) irradiating the x-ray marker 244 with x-ray radiation and

f) moving the object 270 into the distal basket interior 222.

Optionally, the object 270 enters the distal basket interior 222adjacent to (preferably adjacent and immediately distal to) at least oneof the unattached, distal-pointing crowns 258—i.e., in the enlargedcells/drop zones 262. In some embodiments, the distal body 216 isdeployed so that at least one (e.g., preferably the two proximal 258Aand 258B) of the unattached, distal-pointing crowns 258 is distal to theobject 270. As explained below, the x-ray markers 244 of the unattached,distal-pointing crowns 258 are used to locate the distal body 216relative to the clot or other object 270. It will be appreciated thatclots 270 can generally be located in blood vessels 266 by injecting acontrast dye, for example, into the blood vessel 266 proximal and distalto the believed area of obstruction and viewing on an x-ray where thefluid stops moving in the blood vessel 266. It will also be appreciatedthat if the object 270 is not a blood clot but is a radio-opaque object,the object 270 may be viewed on an x-ray.

FIGS. 11 and 14B illustrate a first, perspective view of one embodimentof a distal body 216 with twisting proximal strips 252, unattacheddistal-pointing crowns 258 that subtly curve inward and have x-raymarkers 244, and enlarged openings/drop zones 262 in the basket 246 thatallow the obstruction or other object 270 to enter. In FIGS. 11 and 14B,the distal body 216 is in Orientation 1. (To prepare a basket 246 withunattached distal-pointing crowns 258 that curve inward toward thebasket interior 292, a mandrel 900 such as that illustrated in FIGS. 63and 64 may be used. The mandrel 900 includes a generally cylindricalbody 901 with tapered proximal and distal ends 902 and 903 that slopelike the ends of a pencil. The cylindrical body 901 includes two grooves904 that extend around the circumference of the cylindrical body 901.The grooves 904 include tapered portions 905 that slope towards thedistal end 903, which are designed to shape the unattacheddistal-pointing crowns 258. The grooves 904 are generally in the shapeof a truncated cone, as shown in FIGS. 30-31). The two proximal,unattached distal-pointing crowns 258A and 258B are locatedapproximately the same distance from the proximal hub/junction/tube 228and are oriented approximately 180 degrees relative to each other. Thetwo distal, unattached distal-pointing crowns 258C and 258D are locatedapproximately the same distance from the proximal hub/junction/tube 228as each other (and distal to the two proximal, unattacheddistal-pointing crowns 258A and 258B) and are oriented approximately 180degrees relative to each other and approximately 90 degrees to theproximal, unattached distal-pointing crowns 258A and 258B. For example,for purposes of FIGS. 11-29, “approximately the same distance from theproximal hub/junction/tube 228” means that if one free distal crown 258Aof the first pair of distal crowns 258A/258B is located X distance fromthe proximal hub/junction/tube 228, the other distal crown 258B of thefirst pair of distal crowns 258A/258B is located X distance plus orminus (+/−) 3 millimeters (mm) from the proximal hub/junction/tube 228.Similarly, if one free distal crown 258C of the second pair of distalcrowns 258C/258D is located Y distance from the proximalhub/junction/tube 228, the other distal crown 258D of the second pair ofdistal crowns 258C/258D is located Y distance plus or minus (+/−) 3 mmfrom the proximal hub/junction/tube 228. In a preferred embodiment, thefirst free distal crowns 258A and 258B are located the same distance+/−0.5 mm from the proximal hub/junction/tube 228. Similarly, in apreferred embodiment, the second free distal crowns 258C and 258D arelocated the same distance +/−0.5 mm from the proximal hub/junction/tube228.

The two proximal enlarged openings/drop zones 262A and 262B distal tothe proximal, unattached distal pointing crowns 258A and 258B arelocated approximately the same distance from the proximalhub/junction/tube 228 and the centers of the two proximal enlargedopenings/drop zones 262A and 262B are oriented approximately 180 degreesrelative to each other. (As noted above, preferably, the proximal,unattached distal-pointing crowns 258A and 258B form part of theproximal boundary of the proximal, enlarged cells/drop zones 262A and262B, and the distal, unattached distal-pointing crowns 258C and 258Cform part of the proximal boundary of the distal, enlarged cells/dropzones 262C and 262D). The two distal, enlarged openings/drop zones 262Cand 262D distal to the distal, unattached distal pointing crowns 258Cand 258D are located approximately the same distance from the proximalhub/junction/tube 228 and the centers of the distal, enlargedopenings/drop zones 262C and 262D are oriented approximately 180 degreesrelative to each other and approximately 90 degrees relative to theproximal enlarged openings/drop zones 262A and 262B. FIGS. 12A and 14Cillustrate a second view of the distal body 216 of FIG. 11 (Orientation2). FIG. 13 is a close-up view of two unattached, distal-pointing crowns262. The lines in FIG. 14 show how a nitinol tube 264 is cut with alaser to create the distal body 216 shown in FIG. 14B and FIG. 14C. Itwill be appreciated that FIG. 14B is a simplified view of the distalbody 216 and orientation shown in FIG. 11 and FIG. 14C is a simplifiedview of the distal body 216 and orientation shown in FIG. 12A.

As described below, FIGS. 15-19 describe how the distal body 216 is usedto retrieve, soft clots 270A, hard clots 270B, and deformable, cohesiveadhesive clots 270C in a human intracranial artery 266. (In FIGS. 15-19,the center of the artery 266 is denominated by the dashed line). Asexplained below, the distal body 216 has four rows of x-ray markersnamely, 1) a first row of one x-ray marker, which is located inside theproximal tube denominated by the numeral 228, 244; 2) a second row oftwo x-ray markers, which are located at the two proximal, unattacheddistal-pointing crowns (the two markers are oriented 180 degreesrelative to each other) denominated by the numerals 258A, 244 and 258B,244; 3) a third row of two x-ray markers, which are located at the twodistal, unattached distal-pointing crowns (these two markers areoriented 180 degrees relative to each other and 90 degrees relative tothe two proximal, unattached distal-pointing crowns) denominated by thenumerals 258C, 244 and 258D, 244; and 4) a fourth row of one x-raymarker, which is located inside the distal tube denominated by thenumeral 236, 244. (It will be appreciated that the first number in thesequence describes the position of the x-ray marker and the secondnumber, 244, represents the fact that the item is an x-ray marker). Asexplained below, upon deploying the distal body 216 so that the twoproximal, unattached distal-pointing crowns 258A, 244 and 258B, 244 areimmediately distal to the clot 270, the surgeon interventionalist (i.e.,operator of the distal body 216) detects the four rows of x-ray markersusing x-ray radiation from a first vantage point and from a secondvantage point that is offset from the first vantage point (e.g. 90degrees). Next, the surgeon moves the distal body 216 proximallyrelative to the clot 270 and takes additional x-rays from the first andsecond vantage points. As explained in greater detail below, the surgeonuses the x-ray markers of the proximal and distal, unattacheddistal-pointing crowns, namely 258A, 244; 258B, 244; 258C, 244; and258D, 244 (more specifically, the convergence or lack thereof of theproximal and distal, unattached distal-pointing crowns 258A, 244; 258B,244; 258C, 244; and 258D, 244 as shown on the x-ray) to determinewhether the clot 270 is located inside the distal body interior 222 orwhether the clot 270 is collapsing the distal body 216.

More specifically, FIGS. 15A-G illustrate stepwise use of the distalbody 216 in retrieving a soft clot 270A in a human intracranial artery266. (The distal body 216 in FIGS. 15A-15G is in Orientation 1). First,as always, the surgeon determines the location of the clot 270A in thevessel 266 using, for example, a contrast dye injected proximal anddistal to the clot 270A. Next, the delivery catheter 208, which isenveloping the distal body 216, is positioned in the blood vessel 266 sothat the two proximal, unattached distal-pointing crowns 258A and 258Bare immediately distal to the clot 270A. See FIG. 15B. The distal body216 is then deployed from the delivery catheter 208 by moving thecatheter 208 proximally. The soft clot 270A, which is unable to collapsethe distal body 216, then enters the distal body interior 222. See FIG.15C. However, at this time, the surgeon is unaware that the clot 270Ahas entered into the distal body interior 222. Thus, without moving thedistal body 216, the surgeon irradiates the four rows of x-ray markersat a first vantage point (i.e., from the front of the distal body 216 inthe orientation shown in FIGS. 15A-G; i.e., into the page). As shown inFIG. 15D, the first vantage point shows four rows of x-ray markers. Thefirst row is a single point, which represents the x-ray marker locatedin the proximal tube 228, 244; the proximal tube x-ray marker 228, 244always appears as a single point. The second row is a single point,which represents the x-ray marker located at the front, proximal,unattached distal-pointing crown 258B, 244; the reason that this secondrow of markers is a single point is that the rear x-ray marker of thesecond row 258A, 244 is hidden from view because it is directly behindthe front x-ray marker of the second row 258B, 244. The third row hastwo points, which represents the two x-ray markers located at thedistal, unattached distal-pointing crowns 258C, 244 and 258D, 244; thereason that this third row of markers has two points is that neithermarker in the third row 258C, 244 and 258D, 244 is hidden from view onthe x-ray at this angle—rather, one marker 258C, 244 is located abovethe other marker 258D, 244—and as shown in FIG. 15C, the distal body 216is not collapsed at the distal, unattached distal-pointing crowns 258C,244 and 258D, 244. The fourth row is a single point, which representsthe x-ray marker located in the distal tube 236, 244; the distal tubex-ray marker 236, 244 always appears as a single point. Without movingthe distal body 216, the surgeon then irradiates the four rows of x-raymarkers from a second vantage point 90 degrees offset from the firstvantage point (i.e., from the bottom of the distal body 216 in theorientation shown in FIG. 15A). As shown, the first row is, as always, asingle point, which represents the x-ray marker located in the proximaltube 228, 244. The second row has two points, which represents the twox-ray markers located at the proximal, unattached distal-pointing crown258A, 244 and 258B, 244; the reason that this second row of markersshows up as two points is that neither marker 258A, 244 and 258B, 244 inthe second row is hidden from view on the x-ray at this offsetangle—rather, one marker 258B, 244 is located above the other marker258A, 244—and the distal body 216 is not collapsed at the proximal,unattached distal-pointing crowns 258A, 244 and 258B, 244. The third rowis a single point, which represents the x-ray marker located at thebottom, distal, unattached distal-pointing crown 258D, 244; the reasonthat this third row of markers is a single point is that the top x-raymarker of the third row 258C, 244 is directly behind the bottom x-raymarker of the third row 258D, 244, and thus, hidden from view. Thefourth row is, as always, a single point, which represents the x-raymarker located in the distal tube 236, 244. The surgeon, thus, concludesthat neither the x-ray markers at the second row 258A, 244 and 258B, 244nor the x-ray markers at the third row 258C, 244 and 258D, 244 (i.e.,the x-ray markers at both the proximal and distal unattached distalpointing-crowns) have converged. As shown in FIG. 15E, the surgeon thenmoves the distal body 216 proximally relative to the soft clot 270A sothat the distal, unattached distal-pointing crowns 258C, 244 and 258D,244 are immediately distal to the clot 270A and then the surgeonirradiates the four rows of x-ray markers again from the first vantagepoint and the second vantage point. As shown in FIG. 15F, the resultsare the same as FIG. 15D. With the results from FIGS. 15D and 15F, thesurgeon concludes that neither x-ray markers at the second row 258A, 244and 258B, 244 nor the x-ray markers at the third row 258C, 244 and 258D,244 (i.e., the x-ray markers at both the proximal and distal unattacheddistal pointing-crowns) converged at either the original position of thedistal body 216 (FIGS. 15C and 15D) or the position after moving thedistal body 216 proximally (FIGS. 15E and 15F), and, thus, the distalbody 216 was expanded in the vessel 266 in both positions. Thus, thesurgeon concludes that the clot is a soft clot 270A that has enteredinto the distal body interior 222 and the surgeon removes the distalbody 216 and the soft clot 270A, captured by the distal body 216, bymoving the distal body 216 proximally out of the vessel 266, as shown inFIG. 15G.

FIGS. 16A-H illustrate stepwise use of the distal body 216 in retrievinga hard clot 270B in a human intracranial artery 266. (In FIGS. 16A-H,the distal body 216 is in Orientation 1). First, as always, the surgeondetermines the location of the clot 270B in the vessel 266 using, forexample, a contrast dye injected proximal and distal to the clot 270B.Next, the delivery catheter 208, which is enveloping the distal body216, is positioned in the blood vessel 266 so that the two proximal,unattached distal-pointing crowns 258A and 258B are immediately distalto the clot 270B. See FIG. 16B. The distal body 216 is then deployedfrom the delivery catheter 208 by moving the catheter 208 proximally.The hard clot 270B, which is located above the distal body 216,collapses the distal body 216, as shown in FIG. 16C. However, at thistime, the surgeon is unaware that the clot 270B has collapsed the distalbody 216. Thus, without moving the distal body 216, the surgeonirradiates the x-ray markers at a first vantage point (i.e., from thefront of the distal body 216; i.e., into the page). As shown in FIG.16D, the first vantage point shows four rows of x-ray markers. The firstrow is, as always, a single point, representing the x-ray marker locatedin the proximal tube—i.e., 228, 244. The second row is a single point,which represents the x-ray marker located at the front, proximal,unattached distal-pointing crown 258B, 244; the reason that this secondrow of markers is a single point is that the rear x-ray marker of thesecond row 258A, 244 is hidden from view because it is directly behindthe front x-ray marker of the second row 258B, 244. The third row hastwo points, which represents the two x-ray markers located at thedistal, unattached distal-pointing crowns 258C, 244 and 258D, 244; thereason that this third row of markers has two points is that neithermarker in the third row is hidden from view on the x-ray at thisangle—rather, one marker 258C, 244 is located above the other marker258D, 244—and as shown in FIG. 16C, the distal body 216 is not collapsedat the distal, unattached distal-pointing crowns 258C, 244 and 258D,244. The fourth row is, as always, a single point, representing thex-ray marker located in the distal tube 236, 244. Without moving thedistal body 216, the surgeon then irradiates the markers from a secondvantage point 90 degrees offset from the first vantage point (i.e., fromthe bottom of the distal body 216). As shown, the first row is, asalways, a single point, which represents the x-ray marker located in theproximal tube 228, 244. The second row has two points, which representsthe two x-ray markers located at the proximal, unattacheddistal-pointing crowns 258A, 244 and 258B, 244; the reason that thissecond row of markers shows up as two points is that neither marker inthe second row is hidden from view on the x-ray at this offsetangle—rather, one marker 258B, 244 is located above the other marker258A, 244—and although the distal body 216 is collapsed at the proximal,unattached distal-pointing crowns as shown in FIG. 16C, the second rowof x-ray markers have not converged because the clot 270B is on top ofthe second row of x-ray markers. The third row is a single point, whichrepresents the x-ray marker located at the bottom, distal, unattacheddistal-pointing crown 258D, 244; the reason that this third row ofmarkers is a single point is that the top x-ray marker of the third row258C, 244 is directly behind the bottom x-ray marker of the third row258D, 244, and thus, hidden from view. The fourth row is, as always, asingle point, which represents the x-ray marker located in the distaltube 236, 244. The surgeon, thus, concludes that neither the second row258A, 244 and 258B, 244 nor the third row 258C, 244 and 258D, 244 ofx-ray markers (i.e., the x-ray markers at both the proximal and distalunattached distal pointing-crowns) has converged. As shown in FIG. 16E,the surgeon then moves the distal body 216 proximally so that thedistal, unattached distal-pointing crowns 258C, 244 and 258D, 244 areimmediately distal to the clot 270B and the surgeon then irradiates thex-markers again from the first vantage point. As shown in FIG. 16F, thefirst row is, as always, a single point, representing the x-ray markerlocated in the proximal tube 228, 244. The second row is a single point,which represents the x-ray marker located at the front, proximal,unattached distal-pointing crown 258B, 244; the reason that this secondrow of markers is a single point is that the rear x-ray marker of thesecond row 258A, 244 is hidden from view because it is directly behindthe front x-ray marker of the second row 258B, 244. The third row hasonly one point because the clot 270B, which is on top of the third rowof x-ray markers 258C, 244 and 258D, 244 (i.e., the markers at thedistal, unattached distal-pointing crowns), has pushed the third row ofx-ray markers 258C, 244 and 258D, 244 together. The fourth row is, asalways, a single point, representing the x-ray marker located in thedistal tube 236, 244. Without moving the distal body 216, the surgeonthen irradiates the markers from a second vantage point 90 degreesoffset from the first vantage point (i.e., from the bottom of the distalbody). As shown, the first row is, as always, a single point, whichrepresents the x-ray marker located in the proximal tube 228, 244. Thesecond row has two points, which represents the two x-ray markerslocated at the proximal, unattached distal-pointing crown 258A, 244 and258B, 244; the reason that this second row of markers shows up as twopoints is that neither marker in the second row is hidden from view onthe x-ray at this offset angle and the distal body 216 is not collapsedat the proximal, unattached distal-pointing crowns 258A, 244 and 258B,244. The third row is a single point, which represents the x-ray markerlocated at the bottom, distal, unattached distal-pointing crown 258D,244; the reason that this third row of markers is a single point is thatthe bottom x-ray marker of the third row 258D, 244 is directly in frontof the top x-ray marker of the third row 258C, 244, and thus, the topx-ray marker of the third row 258C, 244 is hidden from view. The fourthrow is, as always, a single point, which represents the x-ray markerlocated in the distal tube 236, 244. Knowing that the distal, unattacheddistal-pointing crowns 258C, 244 and 258D, 244 have converged as shownin FIG. 16F, the surgeon moves the distal body 216 proximally and thehard clot 270B falls into the distal body interior 222 in the enlargedcell/drop zone 262C immediately distal to the top, distal, unattacheddistal-pointing crown 258C. See FIG. 16G. To confirm that the hard clot270B has entered the distal body interior 222, the surgeon takes x-raysfrom the first and second vantage points. The results are shown in FIG.16H. As compared to 16F, the front x-ray view of FIG. 16H shows that thedistal, unattached distal-pointing crowns 258C, 244 and 258D, 244 arenot converged, and, thus, the surgeon concludes that the hard clot 270Bhas entered the distal body interior 222. The surgeon then removes thedistal body 216 and the hard clot 270B, captured by the distal body 216,by moving the distal body 216 proximally out of the vessel 266.

FIGS. 17A-G illustrate stepwise use of the distal body 216 in retrievinga soft clot 270A in a human intracranial artery 266. (In FIGS. 17A-G,the distal body 216 is in Orientation 2). First, as always, the surgeondetermines the location of the clot 270A in the vessel 266 using, forexample, a contrast dye injected proximal and distal to the clot 270A.Next, the delivery catheter 208, which is enveloping the distal body216, is positioned in the blood vessel 266 so that the two proximal,unattached distal-pointing crowns 258A and 258B are immediately distalto the clot 270A. See FIG. 17B. The distal body 216 is then deployedfrom the catheter 208 by moving the catheter 208 proximally. The softclot 270A, which is unable to collapse the distal body 216, then entersthe distal body interior 222. See FIG. 17C. However, at this time, thesurgeon is unaware that the clot 270A has entered into the distal bodyinterior 222. Thus, without moving the distal body 216, the surgeonirradiates the x-ray markers at a first vantage point (i.e., from thefront of the distal body; into the page). As shown in FIG. 17D, thefirst vantage point shows four rows of x-ray markers. The first row is,as always, a single point, representing the x-ray marker located in theproximal tube 228, 244. The second row has two points, which representsthe two x-ray markers located at the proximal, unattacheddistal-pointing crowns 258A, 244 and 258B, 244; the reason that thissecond row of markers has two points is that neither marker in thesecond row is hidden from view on the x-ray at this angle—rather, onemarker 258A, 244 is located above the other marker 258B, 244—and asshown in FIG. 17C, the distal body 216 is not collapsed at the proximal,unattached distal-pointing crowns 258A, 244 and 258B, 244. The third rowhas a single point, which represents the x-ray marker located at thefront (in Orientation 2), distal, unattached distal-pointing crown 258C,244; the reason that this third row of markers is a single point is thatthe rear (in Orientation 2) x-ray marker 258D, 244 of the third row ishidden from view because it is directly behind the front x-ray marker258C, 244 of the third row. The fourth row is, as always, a singlepoint, representing the x-ray marker located in the distal tube 236,244. Without moving the distal body, the surgeon then irradiates themarkers from a second vantage point 90 degrees offset from the firstvantage point (i.e., from the bottom of the distal body, as shown inthis view). As shown, the first row is, as always, a single point, whichrepresents the x-ray marker located in the proximal tube 228, 244. Thesecond row is a single point, which represents the x-ray marker locatedat the bottom (in Orientation 2), proximal, unattached distal-pointingcrown 258B, 244; the reason that this second row of markers is a singlepoint is that the top (in Orientation 2) x-ray marker of the second row258A, 244 is directly behind the bottom x-ray marker of the second row258B, 244, and thus, hidden from view. The third row has two points,which represents the two x-ray markers located at the distal, unattacheddistal-pointing crowns 258C, 244 and 258D, 244; the reason that thisthird row of markers shows up as two points is that neither marker inthe third row is hidden from view on the x-ray at this offset angle andthe distal body 216 is not collapsed at the distal, unattacheddistal-pointing crowns 258C, 244 and 258D, 244. The fourth row is, asalways, a single point, which represents the x-ray marker located in thedistal tube 236, 244. The surgeon, thus, concludes that neither thesecond row 258A, 244 and 258B, 244 nor the third row of x-ray markers258C, 244 and 258D, 244 (i.e., the x-ray markers at both the proximaland distal unattached distal pointing-crowns) has converged. As shown inFIG. 17E, the surgeon then moves the distal body 216 proximally relativeto the clot 270A so that the distal, unattached distal-pointing crowns258C, 244 and 258D, 244 are immediately distal to the clot 270A and thenthe surgeon irradiates the x-markers again from the first vantage pointand the second vantage point. As shown in FIG. 17F, the results are thesame as FIG. 17D. With the results from FIGS. 17D and 17F, the surgeonconcludes that neither the second row 258A, 244 and 258B, 244 nor thethird row of x-ray markers 258C, 244 and 258D, 244 (i.e., the x-raymarkers at both the proximal and distal unattached distalpointing-crowns) were converged at either the original position of thedistal body 216 (FIGS. 17C and 17D) or the position after moving thedistal body 216 proximally (FIGS. 17E and 17F), and, thus, the distalbody 216 was expanded in the vessel 266 in both positions. Thus, thesurgeon concludes that the clot 270A is a soft clot 270A that hasentered into the distal body interior 222 and the surgeon removes thedistal body 216 and the soft clot 270A, captured by the distal body 216,by moving the distal body 216 proximally out of the vessel 266, as shownin FIG. 17G.

FIGS. 18A-G illustrate stepwise use of the distal body 216 in retrievinga hard clot 270B in a human intracranial artery 266. (In FIGS. 18A-G,the distal body 216 is in Orientation 2). (As described below, theprimary differences between FIGS. 18A-G and FIGS. 16A-G is that the clot270B enters the distal body interior 222 in an enlarged cell/drop zone262A immediately distal to one of the proximal, unattacheddistal-pointing crowns 258A in FIGS. 18A-G, as compared to FIGS. 16A-Gwhere the clot 270B enters the distal body interior 222 in an enlargedcell/drop zone 262C immediately distal to one of the distal, unattacheddistal-pointing crowns 258C). First, as always, the surgeon determinesthe location of the clot 270B in the vessel 266 using, for example, acontrast dye injected proximal and distal to the clot 270B. Next, thedelivery catheter 208, which is enveloping the distal body 216, ispositioned in the blood vessel 266 so that the two proximal, unattacheddistal-pointing crowns 258A and 258B are immediately distal to the clot270B. See FIG. 18B. The distal body 216 is then deployed from thecatheter 208 by moving the catheter 208 proximally. The hard clot 270B,which is located above the distal body 216, collapses the distal body216, as shown in FIG. 18C. However, at this time, the surgeon is unawarethat the clot 270B has collapsed the distal body 216. Thus, withoutmoving the distal body 216, the surgeon irradiates the x-ray markers ata first vantage point (i.e., from the front of the distal body inOrientation 2; into the page). As shown in FIG. 18D, the first vantagepoint shows four rows of x-ray markers. The first row is, as always, asingle point, representing the x-ray marker located in the proximal tube228, 244. The second row has only one point because the clot 270B, whichis on top of the second row of x-ray markers 258A, 244 and 258B, 244(i.e., the markers at the proximal, unattached distal-pointing crowns),has pushed them together. The third row has only one point, whichrepresents the x-ray marker located at the front (in Orientation 2),proximal, unattached distal-pointing crown 258C, 244; the reason thatthis third row of markers is a single point is that the rear (in thisview) x-ray marker of the third row 258D, 244 is hidden from viewbecause it is directly behind the front x-ray marker of the third row258C, 244. The fourth row is, as always, a single point, representingthe x-ray marker located in the distal tube 236, 244. Without moving thedistal body, the surgeon then irradiates the markers from a secondvantage point 90 degrees offset from the first vantage point (i.e., fromthe bottom of the distal body 216). As shown, the first row is, asalways, a single point, which represents the x-ray marker located in theproximal tube 228, 244. The second row has a single point because thetop (in Orientation 2) x-ray marker of the second row 258A, 244 islocated behind the bottom (in Orientation 2) x-ray marker 258B, 244 andthus, the top x-ray marker of the second row 258A, 244 is hidden fromview. The third row has two points, which represents the x-ray markerslocated at the distal, unattached distal-pointing crowns 258C, 244 and258D, 244; in this x-ray view neither of the x-ray markers of the thirdrow is hidden from view. The fourth row is, as always, a single point,which represents the x-ray marker located in the distal tube 236, 244.The surgeon, thus, concludes that the second row of x-ray markers 258A,244 and 258B, 244 (i.e., the x-ray markers at the proximal, unattacheddistal pointing-crowns) has converged. As shown in FIG. 18E, the surgeonthen moves the distal body 216 proximally so that the distal, unattacheddistal-pointing crowns 258C, 244 and 258D, 244 are immediately distal tothe clot 270B. Unbeknownst to the surgeon, the clot 270B enters thedistal body interior 222 immediately distal to the top (in Orientation2), proximal unattached distal-pointing crown 258A and the distal body216 is no longer collapsed. The surgeon then irradiates the x-markersagain from the first vantage point. As shown in FIG. 18F, the first rowis, as always, a single point, representing the x-ray marker located inthe proximal tube 228, 244. The second row has two x-ray markers becausethe distal body 216 is not collapsed and neither the top (in Orientation2) 258A, 244 nor the bottom 258B, 244 (in Orientation 2) x-ray marker ofthe second row (i.e., the marker at the proximal, unattacheddistal-pointing crowns) is hidden from view. The third row has only onepoint because the rear (in Orientation 2), distal unattacheddistal-pointing crown 258D, 244 is hidden behind the front (inOrientation 2), distal, unattached distal pointing-crown 258C, 244. Thefourth row is, as always, a single point, representing the x-ray markerlocated in the distal tube 236, 244. Without moving the distal body 216,the surgeon then irradiates the markers from a second vantage point 90degrees offset from the first vantage point (i.e., from the bottom ofthe distal body 216). As shown, the first row is, as always, a singlepoint, which represents the x-ray marker located in the proximal tube228, 244. The second row has a single point because the x-ray marker atthe top (in Orientation 2), proximal, unattached distal-pointing crown258A, 244 is hidden behind the bottom (in Orientation 2), proximal,unattached-distal pointing crown 258B, 244. The third row has two pointsbecause neither the front nor the rear x-ray markers at the distal,unattached, distal-pointing crowns 258C, 244 and 258D, 244 is hiddenfrom view. The fourth row is, as always, a single point, whichrepresents the x-ray marker located in the distal tube 236, 244. Basedon the information from FIGS. 18D and 18F, the surgeon concludes thatthe clot 270B has entered into the distal body interior 222. The surgeonthen removes the distal body 216 and the hard clot 270B, captured by thedistal body 216, by moving the distal body 216 proximally out of thevessel 266, as shown in FIG. 18G. Upon comparing FIGS. 16A-G and FIGS.18A-G it will be appreciated that the orientation of the enlargedcells/drop zone 262A-D relative to the orientation of a hard clot 270Bdetermine which enlarged cell/drop zone 262A, 262B, 262C, or 262D, thehard clot 270 enters the distal body interior 222 through. For example,in FIG. 16C, the hard clot 270B is located above the distal body 216,and thus, the hard clot 270B must enter through the enlarged cell/dropzone located at the top of the distal body, which in the orientation ofthe distal body shown in FIGS. 16A-G, is the enlarged cell/drop zone262C immediately distal to the top, distal, unattached, distal-pointingcrown 258C. In FIG. 18C, the hard clot 270B is again located above thedistal body and, thus, the hard clot 270B must enter through theenlarged cell/drop zone located at the top of the distal body. However,in FIG. 18C, the enlarged cell/drop zone located at the top of thedistal body 216, in the orientation of the distal body 216 shown inFIGS. 18A-G, is the enlarged cell/drop zone 262A immediately distal tothe top, proximal, unattached, distal-pointing crown 258A.

FIGS. 19A-N illustrate stepwise use of the distal body 216 in retrievinga deformable cohesive, adherent clot 270C—i.e., a clot that is difficultto break up and is tightly adhered to the vessel wall 268—in a humanintracranial artery 266. (In FIGS. 19A-N, the distal body 216 is inOrientation 2). First, as always, the surgeon determines the location ofthe clot 270C in the vessel 266 using, for example, a contrast dyeinjected proximal and distal to the clot 270C. Next, the deliverycatheter 208, which is enveloping the distal body 216, is positioned inthe blood vessel 266 so that the two proximal, unattacheddistal-pointing crowns 258A and 258B are immediately distal to the clot270C. See FIG. 19B. The distal body 216 is then deployed from thecatheter 208 by moving the catheter 208 proximally. The deformable,cohesive adherent clot 270C, which is located above the distal body 216,collapses the distal body 216, as shown in FIG. 19C. However, at thistime, the surgeon is unaware that the clot 270C has collapsed the distalbody 216. Thus, without moving the distal body 216, the surgeonirradiates the x-ray markers at a first vantage point (i.e., from thefront of the distal body; i.e., into the page). As shown in FIG. 19D,the first vantage point shows four rows of x-ray markers. The first rowis, as always, a single point, representing the x-ray marker located inthe proximal tube 228, 244. The second row has a single point,corresponding to the top (in Orientation 2) and bottom (in Orientation2), proximal, unattached distal-pointing crowns 258A, 244 and 258B, 244,which have converged because the clot 270C is collapsing the distal body216. The third row has a single point, which represents the x-ray markerlocated at the front (in Orientation 2), distal, unattacheddistal-pointing crown 258C, 244; the x-ray marker located at the rear,distal, unattached distal-pointing crown 258D, 244 is hidden from view.The fourth row is, as always, a single point, representing the x-raymarker located in the distal tube 236, 244. Without moving the distalbody 216, the surgeon then irradiates the markers from a second vantagepoint 90 degrees offset from the first vantage point (i.e., from thebottom of the distal body). As shown, the first row is, as always, asingle point, which represents the x-ray marker located in the proximaltube 228, 244. The second row has a single point, which corresponds tothe bottom (in Orientation 2), proximal, unattached distal-pointingcrown 258B, 244; the top (in Orientation 2), proximal, unattacheddistal-pointing crown 258A, 244 is located behind the bottom, proximal,unattached distal-pointing crown 258B, 244 and hidden from view. Thethird row has two points, which correspond to the front (in Orientation2) 258C, 244 and rear 258D, 244 (in Orientation 2), distal, unattacheddistal-pointing crowns, neither of which is blocked in this view. Thefourth row is, as always, a single point, which represents the x-raymarker located in the distal tube 236, 244. As shown in FIG. 19E, thesurgeon then moves the distal body 216 proximally (i.e., slightlywithdraws the distal body 216). The surgeon then irradiates thex-markers again from the first and second vantage points. As shown inFIG. 19F, the results are exactly the same as in FIG. 19D. Based on theobservation that the proximal, unattached distal-pointing crowns 258A,244 and 258B, 244 have converged at both the original position (FIGS.19C and 19D in which the proximal, unattached distal-pointing crowns258A, 244 and 258B, 244 are immediately distal to the clot 270C) and thesecond position (FIGS. 19E and 19F), the surgeon concludes that the clot270C is a deformable cohesive, adherent clot 270C. The surgeon thenoscillates the distal body 216 proximally and distally a small distance(e.g., about 1 mm to about 2 mm) in the vessel 266, and the clot 270Cbegins to enter the distal body 216, as shown in FIG. 19G. The surgeonthen irradiates the x-markers again from the first and second vantagepoints. As shown in FIG. 19H, the results are exactly the same as inFIG. 19D and FIG. 19F except that the second row of markers 258A, 244and 258B, 244 (at the proximal, unattached distal-pointing crowns) arebeginning to move apart. The surgeon then moves the distal body 216proximally again, as shown in FIG. 19I. The surgeon then irradiates thex-markers again from the first and second vantage points. As shown inFIG. 19J, the results are exactly the same as in FIGS. 19D and 19F, asthe clot 270C has caused the second row of markers 258A, 244 and 258B,244 to re-converge. The surgeon then oscillates the distal body 216proximally and distally a small distance (e.g., about 1 mm to about 2mm) in the vessel 266, and the clot 270C begins to further enter thedistal body interior 222, as shown in FIG. 19K. The surgeon thenirradiates the x-markers again from the first and second vantage points.As shown in FIG. 19L, the results are the same as in FIG. 19H. Thesurgeon then moves the distal body 216 again proximally, and, instead ofcollapsing the second row of markers 258A, 244 and 258B, 244, the clot270C fully enters the distal body interior 222, as shown in FIG. 19M.The surgeon then irradiates the x-markers again from the first andsecond vantage points. As shown in FIG. 19N, the results show that thesecond row of markers 258A, 244 and 258B, 244 (at the proximal,unattached distal-pointing crowns) have moved apart. Satisfied that thex-ray markers in the second row 258A, 244 and 258B, 244 (at theproximal, unattached distal-pointing crowns) are sufficiently far apartand that the x-ray markers in the third row (at the distal, unattacheddistal-pointing crowns) 258C, 244 and 258D, 244 have stayed far apart,the surgeon concludes that the deformable cohesive, adherent clot 270Chas been sufficiently captured by the distal body 216 and the surgeonthen removes the distal body 216 and the clot 270C, captured by thedistal body 216, by moving the distal body 216 proximally out of thevessel 266.

Several observations can be made from FIGS. 15-19, as indicated above.For example, the x-ray markers at the proximal and distal, unattacheddistal-pointing crowns 258A-D, 244 provide the surgeon feedbackconcerning the interaction between the distal body 216 and the clot 270in the blood vessel 266. In addition, the guiding principle of a softclot 270A is that the soft clot 270A does not collapse the distal body216, and thus, x-ray markers at the proximal and distal, unattacheddistal-pointing crowns 258A-D, 244 always appear as two points exceptwhen a marker is hidden behind another marker (due to the view). When itcomes to a hard clot 270B, the hard clot 270B is generally able to enterthe distal body interior 222 without needing to oscillate the distalbody 216 proximally and distally (unlike a deformable cohesive, adherentclot 270C). However, to capture the hard clot 270B, the hard clot 270Bmust be oriented properly relative to the enlarged cell/drop zones 262A,262B, 262C, or 262D. (This is the reason that the distal body 216 hasfour enlarged cells/drop zones: one enlarged cells/drop zone at 0degrees 262B, one enlarged cells/drop zone at 90 degrees 262C, oneenlarged cells/drop zone at 180 degrees 262A and one enlarged cells/dropzone at 270 degrees 262D). As a guiding principle, an enlarged cell/dropzone 262A, 262B, 262C, or 262D is properly oriented to the clot 270Bwhen the x-ray markers at the proximal, unattached distal-pointingcrowns 258A, 244 and 258B, 244 or the distal, unattached distal pointingcrowns 258C, 244 and 258D, 244 are together at both a first x-ray viewand a second x-ray view 90 degrees relative to the first x-ray view, andthe hard clot 270B can enter the enlarged cell/drop zone 262A, 262B,262C, or 262D by moving the distal body 216 proximally. See FIGS. 16Fand 18D. Finally, the guiding principal of retrieval of deformablecohesive, adherent clots 270C is that oscillation of the distal body 216causes the deformable cohesive, adherent clots 270C to gradually enterthe distal basket interior 222 over time.

FIGS. 20A, 20B and 20C show a distal body 216 that is similar to thedistal body 216 of FIGS. 14A, 14B and 14C except that the distal body216 of FIGS. 20A, 20B and 20C is slightly shorter and its unattached,distal-pointing crowns 258A, 258B, 258C, and 258D are closer to theproximal tube 228. The shortened distal body 216 of FIGS. 20A, 20B and20C is particularly adapted for tortuous blood vessels 266. FIG. 21-29show stepwise deployment of the distal body 216 of FIGS. 20A, 20B and20C in use with a manual (i.e., hand-operated), volume-dependent (i.e.volume locked) suction catheter 272 that is locked at between about 10to about 60 cubic centimeters (cc). Optionally, the suction catheter 272has an outer diameter of between about 0.05 inches and about 0.09 inchesand its outer diameter is substantially larger than the outer diameterof the delivery catheter 208. The clot 270 is located in the vessel 266through the use of, for example, contrast dye injected proximal anddistal to the clot 270. As shown in FIG. 21, a delivery catheter 208containing the distal body 216 of FIGS. 20A, 20B and 20C is positionedin the tortuous vessel 266 distal to the clot 270. The delivery catheter208 is withdrawn, deploying the distal body 216. See FIG. 22. The distalbody 216 is moved proximally relative to the clot 270 and tension isexerted on pull wire 202. See FIG. 23. While maintaining tension on thepull wire 202, a suction catheter 272 having a proximal end 274 and adistal end 276 is delivered over the pull wire 202 that is attached tothe distal body 216. See FIG. 24. (The reason for exerting tension onthe pull wire 202 is that the pull wire 202 serves as the guide/trackfor the movement of the suction catheter 272 and without tension, thesuction catheter 272 and pull wire 202 could end up in the ophthalmicartery 288). The distal end 276 of the suction catheter 272 ispositioned against the clot 270. A syringe 278 is attached to thesuction catheter 272 using a rotating hemostatic valve 290, which allowsthe surgeon to aspirate while a pull wire 202 is in the system. Thesurgeon aspirates the syringe 278 by pulling back on the lever 280 to amark on the base 282 corresponding to between about 10 and about 60cubic centimeters of fluid. The surgeon then locks the lever 280 (andattached plunger) into place, leaving the suction catheter 272 undersuction. The surgeon captures the clot 270 in the distal body 216 usingthe techniques described in FIGS. 15-19. The distal body 216 and clot270 become captured by the suction catheter 272. See FIGS. 27 and 28.The surgeon then removes the suction catheter 272 and the distal body216 and the clot 270, captured by the suction catheter 272, by movingthe suction catheter 272 proximally out of the vessel 266. See FIG. 29.It is believed that the suction catheter 272 would be helpful in theevent that a small portion of the clot 270 breaks off when retrievingthe clot 270 using the distal body 216.

To examine effectiveness of the systems 200, the systems 200 of FIGS.11-20, without the use of a suction catheter 272, were used to retrievesoft and hard clots 270A and 270B induced in a pig weighing between 30to 50 kg. The weight of the pig was chosen so that the size of itsvessels 266 would be approximate to the size of a human vessel. The pigwas anesthetized. Several hard clots 270B were prepared by mixing pigblood and barium and incubating the mixture for 2 hours. Several softclots 270A were prepared by mixing pig blood, thrombin and barium andincubating the mixture for 1 hour. The clots 270A and 270B, each ofwhich had a width of 4 to 6 mm and a length of 10 to 40 mm, were theninserted into a vessel 266 having a diameter of 2 to 4 mm. (Only oneclot 270A and 270B was located in the vessel 266 at a time). Angiogramswere then performed to confirm occlusion. After waiting ten minutesafter confirming occlusion, the distal bodies 216 of FIGS. 11-20 werethen delivered distal to the clots 270A and 270B as described above andwere used to retrieve the clots 270A and 270B as described in FIGS.11-19. In each case, the distal bodies 216 were successful in retrievingthe clots 270A and 270B. As shown, the distal body height in the relaxedstate tapers/decreases as the proximal strips 252 approach the proximalhub/junction/tube 228 and also tapers/decreases as the basket strips 291located at the distal end 220 of the basket 246 converge at the distalhub/junction/tube 236.

The Alternate Embodiment of FIG. 32

FIG. 32 shows a distal body 216 in which the proximal strips proximalends 254 converge and are soldered or welded at the proximalhub/junction 228 and the basket strips 291 located at the distal end 220of the basket 246 converge and are soldered or welded at the distalhub/junction 236. To create such an embodiment, the distal body 216 maybe prepared from a single tube, as described above, and the proximal anddistal tubes may be clipped and the proximal ends 254 of the proximalstrips 252 soldered or welded together (and optionally to the pull wire202) and the basket strips 291 located at the distal end 220 of thebasket 246 may also be welded or soldered or welded together.Optionally, the proximal and distal hubs/junctions 228 and 236 mayinclude x-ray markers 244 as described above.

The Alternate Embodiments of FIGS. 33-35

FIGS. 33A-33C and FIGS. 34A-34B (and the close-up views shown in FIGS.35A and 35B) show an alternate embodiment in which no cells are proximalto the proximal-most cells 250A and 250B that have a free distal crown258A and 258B. (FIGS. 33A-35B do not show the pull wire or catheter,both of which are preferably used with the distal body 216 and shownelsewhere, e.g., in FIGS. 11-20, and FIGS. 33B-33C and FIG. 35A-35B donot show the proximal hub 228). FIGS. 33A-33C has four pair of cells(only a few such cells are labelled with 250 or 250B and visible) withfree distal-pointing crowns 258A-258H, which create four pairs ofenlarged openings 262A-262H. FIGS. 34A-34B has five pair of cells (againnot all labelled) with free distal-pointing crowns 258A-258J, whichcreate five pairs of enlarged openings 262A-262J. More particularly,like FIGS. 11-20, in FIGS. 33A-33C and FIGS. 34A-34B, the distal body216 has a proximal pair of free distal crowns 258A and 258B that havex-ray markers 244 and are located approximately the same distance fromthe proximal junction 228 and between 150 degrees and 180 degrees apartand then a second pair of free distal crowns 258C and 258D that havex-ray markers 244, and are located distal to the proximal pair of freedistal crowns 258A and 258B. Like FIGS. 11-20, in FIGS. 33A-33C andFIGS. 34A-34B, the second pair of distal crowns 258C and 258D arelocated approximately the same distance from the proximal junction 228,are located between 150 degrees and 180 degrees apart and are locatedbetween about 60 degrees and about 90 degrees relative to the proximalpair of free distal crowns 258A and 258B.

The embodiments of FIGS. 33A-33C, FIGS. 34A-34B and FIGS. 35A-35B haveseveral additional features. For example, in FIGS. 33A-33C, FIGS.34A-34B, and FIGS. 35A-35B, the proximal pair of cells 250A and 250Bhaving free distal crowns 258A and 258B each have a proximal crown 297Aand 297B attached to a proximal strip 252. In FIGS. 33A-33C and FIGS.34A-34B, distal to the second pair of free distal crowns 258C and 258D,the distal body 216 has a third pair of free distal crowns 258E and 258Fthat have x-ray markers 244, are located approximately the same distancefrom the proximal junction 228 and are located between 150 degrees and180 degrees apart and are located between about 60 degrees and about 90degrees relative to the second pair of free distal crowns 258C and 258D.In FIGS. 33A-33C and FIGS. 34A-34B, distal to the third pair of freedistal crowns 258E and 258F, the distal body 216 also has a fourth pairof free distal crowns 258G and 258H that have x-ray markers 244, arelocated approximately the same distance from the proximal junction 228and are located between 150 degrees and 180 degrees apart and arelocated between about 60 degrees and about 90 degrees relative to thethird pair of free distal crowns 258E and 258F. In FIGS. 34A-34B, distalto the fourth pair of free distal crowns 258G and 258H, the distal body216 also has a fifth pair of free distal crowns 258I and 258J that havex-ray markers 244, are located approximately the same distance from theproximal junction 228 and are located between 150 degrees and 180degrees apart and are located between about 60 degrees and about 90degrees relative to the fourth pair of free distal crowns 258G and 258H.An advantage having eight unattached distal-pointing crowns 258A-258Hthat are sequentially offset (as in FIGS. 33A-33C) and ten unattacheddistal-pointing crowns 258A-258J that are sequentially offset (as inFIGS. 34A-34B) is that each free distal crown 258A-258J creates anenlarged cell 262A-262J. Thus, in FIGS. 33A-33C and FIGS. 34A-34B, eightand ten, respectively, sequentially offset enlarged cells 262A-262H areformed, creating multiple clot entry points. In FIG. 34A-34B, with theexception of the enlarged cells 262A-262H, all of the cells locatedbetween the cells 250A and 250B (250A is hidden in FIGS. 34A-34B butshown in FIGS. 35A-35B) having the proximal pair of free distal crowns258A and 258B and the cells having the distal-most pair of free distalcrowns 258I and 258J have free distal crowns. Indeed, with the exceptionof the enlarged cells 262A-262H, all of the cells located betweenproximal-most free-distal crowns 258A and 258B and distal-most freecrowns 258I and 258J have free distal crowns 258C-258H. By contrast, thedistal body 216 of FIGS. 33A-33C has an intermediate group of cells 248(i.e., a stent-like structure) with non-free distal crowns (distalcrowns that are attached to a basket strip 291) between the second pairof enlarged openings 262C and 262D and the third pair of enlargedopenings 262E and 262F. In FIG. 34A-34B, all of the cells 248 havingdistal crowns that are attached to a basket strip 291 are located at thedistal end of the distal body 216 (i.e., distal to the distal-mostenlarged openings 262G and 262H) to create a substantially closed distalend of the basket 246 to capture the clot.

In addition, in FIGS. 33A-33C, 34A-34B, FIGS. 35A-35B, the distal body216 has two proximal three-dimensional openings 293 that are located 180degrees apart, as best seen in FIG. 33C and FIG. 34A and the close-upviews of FIGS. 35A and 35B. (The proximal three-dimensional openings 293are aligned and create a continuous void). One such three-dimensionalopening 293 has a proximal end at the intersection point 294 of theproximal strips 252 and a distal end at a distal crown 299 attached to afirst strut 295 located (lengthwise) approximately the same distancefrom the proximal hub/junction 228 as the free distal crowns 258A and258B of the first pair of free distal crowns. The other suchthree-dimensional opening 293 is on the other side of the distal body216 and has a proximal end at the intersection point 294 of the proximalstrips 252 and a distal end at another distal crown 298 attached to asecond strut 296 that is also located (lengthwise) approximately thesame distance from the proximal hub/junction 228 as the free distalcrowns 258A and 258B of the first pair of free distal crowns. The secondstrut 296 is located 180 degrees from the first strut 295. As shown inFIG. 35A, the intersection point 294 of the proximal strips 252 may belocated approximately in the widthwise and heightwise center of thedistal body 216 and the proximal crowns 297A and 297B of theproximal-most cells 250A and 250B having the free distal crowns 258A and258B may be located approximately 150 degrees to 180 degrees apart(e.g., at the 12 o'clock and 6 o'clock positions as shown in FIG. 35Aand the 3 o'clock and 9 o'clock positions in FIG. 35B) and at themaximum height/width of the distal body 216. The proximal crowns 297Aand 297B of the proximal-most cells 250A and 250B having the free distalcrowns 258A and 258B also are attached to the proximal strips 252 asshown in FIGS. 35A and 35B. Similarly, the bridge memory metal strips(distal struts) 295 and 296 may be located approximately 150 degrees to180 degrees apart (e.g., at the 3 o'clock and 9 o'clock positions asshown in FIG. 35A and the 12 o'clock and 6 o'clock positions in FIG.35B), at the maximum height/width of the distal body 216, andapproximately 60 degrees to 90 degrees relative to the free distalcrowns 258A and 258B.

The Embodiments of FIGS. 36-37

FIGS. 36A-36N and 37A-37K (also referred to herein as FIGS. 36-37 forbrevity) show alternate embodiments of distal bodies 216 that aresimilar to the embodiments of FIGS. 11-35. The distal bodies 216 may bemade by any method known in the art including but not limited to thosedescribed in U.S. Pat. No. 9,566,412, the entire contents of which areincorporated herein by reference.

FIGS. 36-37 are CAD drawings drawn to scale. However, it will beappreciated that other dimensions are possible.

More particularly, FIGS. 36-37 provide a system for removing objectsfrom an interior lumen of an animal. The system may include, aspreviously described, a pull wire 202 having a proximal end (not shownin FIGS. 36-37) and a distal end 206. The system of FIGS. 36-37 alsoincludes a distal body 216 that may be attached to the pull wire 202,preferably the pull wire distal end 206. As with the prior embodimentsof FIGS. 11-35, the distal body 216 may include an interior 222, aperimeter 300, a proximal end 218, a distal end 220, a distal bodylength 226 extending from the proximal end 218 to the distal end 220, aproximal junction/hub/tube 228 that may be attached to the pull wire 202and may form the proximal end 218 of the distal body 216, a plurality ofproximal strips 252, a basket 246 comprised of a plurality of cellsformed by a plurality of basket strips 291, and a distaljunction/hub/tube 236 forming a distal end 302 of the basket 246. Aswith the prior embodiments of FIGS. 11-35, the basket 246 may include abasket interior 346, each proximal strip 252 may have a distal end 256attached to a cell and a proximal end 254, the proximal ends 254 of theproximal strips 252 may converge at the proximal junction 228. As withthe prior embodiments of FIGS. 11-35, the distal body 216 may have arelaxed state wherein the distal body 216 has a first height 224 and afirst width 225, and a collapsed state (not shown in FIGS. 36-37)wherein the distal body 216 has a second height and a second width, thesecond height less than the first height 224, the second width less thanthe first width 225. As with prior embodiments, in the embodiments ofFIGS. 36-37, the proximal strips 252 and the basket strips 291 arepreferably comprised of a memory metal.

Like the embodiments of FIGS. 33-35, in the embodiments of FIGS. 36-37,in the relaxed state, the basket 246 may include a series of at leastthree pair of cells 250A-250F located on the distal body perimeter 300having a proximal crown 260 pointing generally in the proximal directionand attached to a memory metal strip (either a proximal strip 252 orbasket strip 291) and a free distal crown 258A-258F pointing generallyin the distal direction. Optionally, as shown in FIGS. 36-37, in theseries, the proximal-most free distal crowns 258A, 258B are located atthe 12 and 6 o'clock positions and located about the same distance fromthe proximal junction 228, the next proximal-most free distal crowns258C, 258D are located at the 3 and 9 o'clock positions and locatedabout the same distance from the proximal junction 228, and thesucceeding proximal-most free distal crowns 258E, 258F are located atthe 12 and 6 o'clock positions (i.e., substantially aligned withproximal-most free distal crowns 258A, 258B) and located about the samedistance from the proximal junction 228. Optionally, each free distalcrown 250A-250F forms part of a different enlarged cell 262A-262F thatis configured to allow a thrombus to enter the basket interior 346. Inother words, like the prior embodiments, the enlarged cells 262A-262Fare designed to capture a clot/thrombus. In the proximal and distal endviews of FIGS. 36M, 36N, 37H, and 37I, miniature clocks with clock handsare used to illustrate the 12, 3, 6 and 9 o'clock positions.

For purposes of FIGS. 36-37, when it is said that a component, such as afree distal crown 258A-258J, is located “about the same distance fromthe proximal junction” 228, if one component (e.g., one free distalcrown 258A of the pair of proximal-most free distal crowns 258A/258B) islocated X distance from the proximal junction 228, the other component(e.g., the other free distal crown 258B of the pair of proximal-mostfree distal crowns 258A/258B) is located X distance plus or minus (+/−)5 millimeters (mm) from the proximal junction 228. In a preferredembodiment, the other component is located X distance plus or minus(+/−) 3 mm from the proximal junction 228, more preferably X distanceplus or minus (+/−) 0.5 mm from the proximal junction 228. (The samerelationship will hold true for the other pairs of free distal crowns258C-258F in the series—e.g., if one free distal crown 258C of the nextproximal-most pair of free distal crowns 258C/258D is located Y distancefrom the proximal junction 228, the other free distal crown 258D of thenext proximal-most pair of free distal crowns 258C/258D is located Ydistance plus or minus (+/−) 5 mm from the proximal junction 228. Again,more preferably the other component is located Y distance plus or minus(+/−) 3 mm from the proximal junction 228, more preferably Y distanceplus or minus (+/−) 0.5 mm from the proximal junction 228. The samerelationship holds true from 258E and 258F.

In FIG. 37, like the embodiment of FIG. 34, the series includes at leastfive pair of cells 250A-250J located on the distal body perimeter 300having a proximal crown 260 pointing generally in the proximal directionand attached to a memory metal strip (either a proximal strip 252 orbasket strip 291) and a free distal crown 258A-258J pointing generallyin the distal direction, and in the series, after the succeeding freedistal crowns 258E, 258F, the next proximal-most free distal crowns258G, 258H are located at the 3 and 9 o'clock positions and locatedabout the same distance from the proximal junction 228 and form enlargedcells 262G, 262H, and the distal-most free distal crowns 258I, 258J arelocated at the 12 and 6 o'clock positions and located about the samedistance from the proximal junction 228 and form the mostdistally-located enlarged cells 262I, 262J. Again, about the samedistance from the proximal hub 228, means the same distance +/−5 mm fromthe proximal junction 228. In a preferred embodiment, 258G/258H arelocated the same distance +/−3 mm from the proximal junction 228, morepreferably the same distance +/−0.5 mm from the proximal junction. Thesame relationship holds true from 258I and 258J.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, the basket 246 may comprise a plurality of distal cells 248Ddistal to the distal-most free distal crown (i.e. 258E, 258F in FIGS. 36and 258I, 258J in FIG. 37) that have a proximal crown attached toanother cell of the basket 246 and pointing generally in the proximaldirection and a distal crown pointing generally in the distal directionand attached to the distal junction 236. In other words, the distalcells 248D are designed to retain a clot/thrombus in the basket interior346.

As with prior embodiments, FIGS. 36-37 illustrate that, in the relaxedstate, each enlarged cell 262A-262J may have a proximal end 308 that maybe comprised of two proximal crowns pointing generally in the proximaldirection, a distal end 310 that may comprise a distal crown pointinggenerally in the distal direction, and a length 312 extending from theproximal end 308 to the distal end 310 of the respective enlarged cell262A-262J.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, each distal cell 248D may have a length 314 extending from theproximal crown to the distal crown 307 of the respective distal cell248D.

As with prior embodiments, FIGS. 36-37, and particularly FIG. 36J,illustrate that in the relaxed state, each of the enlarged cells262A-262J may be longer than each of the distal cells 248D.

As with prior embodiments, FIGS. 36-37, and particularly FIG. 36J,illustrate that in the relaxed state, for each of the enlarged cells262A-262J, the distance 316 from the proximal end 308 of the enlargedcell 262A-262J to the free distal crown 258A-258J of the enlarged cell262A-262J may be less than the distance 318 from the free distal crown258A-258J of the enlarged cell 262A-262J to the distal end 310 of theenlarged cell 262A-262J. In other words, the free distal crowns258A-258J do not protrude far enough into the enlarged cells 262A-262Jto prevent a clot from entering the basket interior 346 through theenlarged cells 262A-262J.

As with prior embodiments, FIGS. 36-37 illustrate that the distal body216 may further comprise a lead wire 286 extending distally from thedistal junction 236. As with prior embodiments but not shown in FIGS.36-37, the system may further comprise a catheter having an interior, aproximal end leading to the interior and a distal end leading to theinterior, the catheter comprised of a biocompatible material andconfigured to envelop the distal body 216 when the distal body 216 is inthe collapsed state. Deployment and use of the system may be as shown inFIGS. 15-29.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, the basket 246 preferably does not have any free crowns thatpoint generally in the proximal direction, as free proximal crowns coulddamage the vessel as mentioned previously.

As with prior embodiments, FIGS. 36-37 illustrate that the distal body216, in the relaxed state, may comprise a distal tapered region 322 inwhich the distal body height 224 and width 225 decrease as the basket246 approaches the distal junction 236.

As with prior embodiments, FIGS. 36-37 illustrate that the distal body216, in the relaxed state may comprise a proximal tapered region 320 inwhich the distal body height 224 and width 225 decrease as the proximalstrips 252 approach the proximal junction 228. It will be appreciatedthat the tapering of the proximal region 320 may take on a variety ofshapes as shown in FIGS. 36 and 37.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, each of the enlarged cells 262A-262J may be longer than each ofthe pair of cells 250A-250J.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, each of the enlarged cells 262A-262J may extend from the 6o'clock position to the 12 o'clock position or the 3 o'clock position tothe 9 o'clock position, as best seen in the close-up views of FIGS. 36C,36E and 36F and 37G but also shown in FIGS. 36A-36B, 36I-36L, 37A-37F.

As with the prior embodiments of FIGS. 11-19 and 21-32, FIG. 36illustrates that in the relaxed state the basket 246 may furthercomprise a plurality of proximal cells 342 proximal to the proximal-mostfree distal crowns 258A, 258B, the plurality of proximal cells 342having a proximal crown attached to the proximal junction 228 andpointing generally in the proximal direction and a distal crown pointinggenerally in the distal direction and attached to another cell of thebasket 246. However, such proximal cells 342 are optional and not shownin FIG. 37, due to the length of the basket 246 which includes tenenlarged cells 262A-262J. If the proximal cells 342 are not included,optionally, as with the prior embodiments of FIGS. 20 and 33-35, FIG. 37illustrates that in the relaxed state the proximal crowns of the cells250A, 250B comprising the proximal-most free distal crowns 258A, 258Bmay be attached to the distal ends 256 of the proximal strips 252.Without being bound by any particular theory, a purpose of the proximalcells 342 may be to allow the clot to rest on the proximal cells 342prior to entering through the enlarged cells 262A-262J.

In preliminary clot capture animal studies using a swine thrombectomymodel, it has been observed the distal body 216 of FIG. 37 isparticularly adept at capturing a clot. (Preliminary clot capture animalstudies were performed using conditions similar to that described in Ulmet al., Preclinical Evaluation of the NeVa™ Stent Retriever: Safety andEfficacy in the Swine Thrombectomy Model, Intery Neurol. 2018 Apr.;7(5):205-217). Without being bound by any particular theory, it isbelieved that the clot capture ability of the distal body 216 of FIG. 37is due to the minimal interference at the enlarged cells 262A-262J(i.e., that the basket strips 291 are flared apart at the distal crownslocated at the distal ends 310 of the enlarged cells 262A-262J).

Thus, as shown in FIG. 37, in the relaxed state, for at least someenlarged cells 262A-262J (preferably for most, more preferably for eachenlarged cell 262A-262J), two basket strips 291 meet to form the distalcrown located at the distal end 310 of the enlarged cell 262A-262J, andthe two basket strips 291 form an angle 328 greater than 65 degrees,more preferably greater than 70 degrees, more preferably greater than 75degrees, more preferably greater than 80 degrees, more preferablygreater than 85 degrees, more preferably greater than 90 degrees, morepreferably greater than 95 degrees, more preferably greater than 100degrees at the respective distal crown located at the distal end 310 ofthe enlarged cell 262A-262J. Preferably, the angle 328 is less than 150degrees. It is believed that the flared nature of the basket strips 291meeting at the distal crown at the distal end 310 of the enlarged cells250A-250J assists in allowing the clot to enter the basket interior 346.By comparison, the basket strips 291 meeting to form the free distalcrowns 258A-258J may have a much smaller angle 326 at the respectivefree distal crown 258A-258J, given that cells 250A-250J are not intendedto be clot capture cells. For example, the angle 326 at the respectivefree distal crown 258A-258J may be less than 50 degrees, more preferablyless than 45 degrees, more preferably less than 40 degrees. In otherwords, for some, most or all enlarged cells 262A-262J, the angle 328 atthe distal crown at the distal end 310 may be at least 2 times (morepreferably at least 2.5 times, more preferably at least 3 times) aslarge as the angle 326 at the free distal crown 258A-258J. Preferably,angle 328 is no more than 5 times as large as angle 326. Due to thesymmetry of the distal body 216, the angle 326 at free distal crown 258Amay be substantially the same as the angle 326 at free distal crown258B, the angle 326 at free distal crown 258C may be substantially thesame as the angle 326 at free distal crown 258D, the angle 326 at freedistal crown 258E may be substantially the same as the angle 326 at freedistal crown 258F, the angle 326 at free distal crown 258G may besubstantially the same as the angle 326 at free distal crown 258H, theangle 326 at free distal crown 258I may be substantially the same as theangle 326 at free distal crown 258J. Similarly, the angle 328 at thedistal crown at the distal end 310 of enlarged cell 262A may besubstantially the same as the angle 328 at the distal crown of enlargedcell 262B, the angle 328 at the distal crown at the distal end 310 ofenlarged cell 262C may be substantially the same as the angle 328 at thedistal crown of enlarged cell 262D, the angle 328 at the distal crown atthe distal end 310 of enlarged cell 262E may be substantially the sameas the angle 328 at the distal crown of enlarged cell 262F, the angle328 at the distal crown at the distal end 310 of enlarged cell 262G maybe substantially the same as the angle 328 at the distal crown ofenlarged cell 262H, and the angle 328 at the distal crown at the distalend 310 of enlarged cell 262I may be substantially the same as the angle328 at the distal crown of enlarged cell 262J.

Because the basket strips 291 may be non-linear, the angles 326 and 328may be determined as if the basket strips 291 were straight from theirproximal ends 330 to their distal ends 332. (See dashed lines 350 and355 in FIG. 37K). In other words, the angles 326 and 328 may be theaverage (mean) angle between the basket strips 291 along the basketstrip lengths. In such measurements, the angles 326 and 328 are measuredby drawing an arc between a point on each basket strip 291 at the sameposition along the distal body length 226. Alternatively, the angles 326and 328 may be the maximum angle between the basket strips 291 along thebasket strip lengths, drawing an arc between a point on each of the twobasket strips 291 at the same position along the distal body length 226.See FIG. 37A, 37E, 37F, 37G for showing how arcs are drawn and maximumangles 326 and 328 are measured.

As an example, the maximum angles 328 between the basket strips 291forming the distal crowns at the distal ends 310 of the enlarged cells262C, 262F, and 262G, as illustrated in FIGS. 37E-37G, are approximately100 degrees, whereas the maximum angles 326 between the basket strips291 forming free distal crowns 258C, 258F, and 258G, as illustrated inFIGS. 37E-37G, by comparison are about 40 degrees. (It should be notedthat the maximum angle 328 between the basket strips 291 forming thedistal crown at the distal end 310 of distal-most enlarged cell 262J, asillustrated in FIG. 37E, is approximately 80 degrees, showing that theremay be variability in the angles 326, 328).

Relatedly, optionally, in the relaxed state, each of the basket strips291 meeting at the distal crown at the distal end 310 of some or all ofthe enlarged cells 250A-250J extends proximally from the respectivedistal crown at the distal end 310 at an angle 348 of at least 32.5degrees, more preferably at least 35 degrees, more preferably at least37.5 degrees, more preferably at least 40 degrees, more preferably atleast 42.5 degrees, more preferably at least 45 degrees, more preferablyat least 47.5 degrees, more preferably at least 50 degrees relative to aline bisecting the respective distal crown that is parallel to thedistal body length 226 as best seen in FIG. 37K. The angle 348 may bedetermined by measuring the basket strip 291 as if it were straight fromthe proximal end 330 to the distal end 332. Thus, for example, eachbasket strip length, as measured from drawing a straight line from theproximal end 330 to the distal end 332 of the basket strip 291 may be atleast 32.5 degrees, more preferably at least 35 degrees, more preferablyat least 37.5 degrees, more preferably at least 40 degrees, morepreferably at least 42.5 degrees, more preferably at least 45 degrees,more preferably at least 47.5 degrees, more preferably at least 50degrees relative to a line bisecting the respective distal crown that isparallel to the distal body length 226 (as well as an adjacent bridgememory metal strip 336, which as explained herein may be substantiallyparallel to the distal body length 226). See FIG. 36K (dotted line 350representing basket strip length, dotted line 226 drawn through therespective distal crown that is parallel to the distal body length 226,and angle 348 between the lines 350 and 226 measuring 45 degrees).Relatedly, for some, most or all the free distal crowns 258A-258J, thebasket strip lengths, as measured from drawing a straight line from theproximal end 330 to the distal end 332 of the basket strip 291 may beless than 25 degrees, more preferably less than 22.5 degrees, morepreferably less than 20 degrees relative to a line that bisects the freedistal crowns 258A-258J and is parallel to the distal body length 226.See FIG. 36K (dotted line 355 representing basket strip length, dottedline 226 drawn through distal crown 258H that is parallel to the distalbody length 226, and angle 354 between the lines 355 and 226 measuring18 degrees at free distal crown 258H). Thus, for some, most or eachenlarged cell 262A-262J, angle 348 at free distal crowns 258A-258J maybe twice, more preferably 2.5 times, more preferably 3 times the size ofangle 354.

Relatedly, in FIG. 37E, which shows a top plan view, the distal ends 332of the basket strips 291 forming the distal crown of enlarged cell 262Jare located approximately in the center of the distal body width 225 andthe proximal ends 330 of the basket strips 291 are located approximatelyat the front and rear of the distal body 216. The proximal end 330 anddistal ends 332 of the basket strips 291 meeting to form the distalcrown located at the distal end 310 of enlarged cell 262H are also shownin the perspective view of FIG. 37G. Optionally, the lengths of eachbasket strip 291 meeting at the distal crown at the distal end 310 ofsome or all of the enlarged cells 250A-250J, as measured from theirproximal ends 330 to their distal ends 332, may be approximately equalto ½ of the distal body width 225 and height 224.

Relatedly, optionally, as shown in the embodiment of FIG. 37 and bestseen in FIG. 37G and 37K, in the relaxed state, for at least someenlarged cells 262A-262J (preferably for each enlarged cell 262A-262J),in the relaxed state, the two basket strips 291 meeting to form thedistal crown located at the distal end 310 of the enlarged cell262A-262J may have distal ends 332 meeting at the respective distalcrown and located approximately in the center of the distal body height224 or width 225 and a proximal end 330 attached to another cell of thebasket 246 and located approximately at the top, bottom or front side,or rear side of the distal body 216. In other words, in FIGS. 37F and37K, which show front and rear elevation views, the distal ends 332 ofthe basket strips 291 forming the distal crown of enlarged cells 262Gand 262H are located approximately in the center of the distal bodyheight 224 and the proximal ends 330 of the basket strips 291 arelocated approximately at the top and bottom of the distal body 216.

As with the prior embodiments of FIGS. 34A-34B, in the distal body 216of FIG. 37, as seen in FIGS. 37E-37F for example, in the relaxed state,due to the space occupied by the ten enlarged cells 250A-250J, from atleast the proximal crowns 260 of the cells 250C, 250D comprising thenext proximal-most free distal crowns 258C, 258D to the proximal ends308 of the enlarged cells 262I, 262J formed by the distal-most pair offree distal crowns 258I, 258J, the basket 246 has no cells other thanthe enlarged cells 262A-262J and the cells 250C-250J comprising the freedistal crowns 258C-258J.

In the distal body 216 of FIG. 36, in the relaxed state, due to thespace occupied by the six enlarged cells 250A-250F, as seen in FIGS.37E-37F for example, from at least the proximal crowns 260 of the cells250C, 250D comprising the next proximal-most free distal crowns 258B,258C to the proximal ends 308 of the enlarged cells 262E, 262F formed bythe succeeding pair of free distal crowns 258E, 258F the basket 246 hasno cells other than the enlarged cells 250A-250F and the cells 262C-262Fcomprising the free distal crowns 258C-258F.

The distal bodies 216 may be substantially symmetrical from front torear and bottom to top, as shown in FIGS. 36I-36L and 37C-37F forexample.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, the distal crowns located at the distal end 310 of the enlargedcells 250A-250J may be attached to another cell of basket 246 (i.e., arenot free floating).

Optionally, as with prior embodiments, in the embodiment of FIG. 36, asbest seen in FIGS. 36J and 36L, in the relaxed state, the basket 246further comprises an additional pair of cells 344 located about the samedistance from the proximal junction 228 as the cells 250A, 250Bcomprising the proximal-most pair of free distal crowns 258A, 258B andlocated at the 9 and 3 o'clock positions, each cell of the additionalpair of cells 344 having a proximal crown attached to a memory metalstrip (either a basket strip 291 or a proximal strip 252) and a distalcrown attached to another cell of the basket 246 (i.e., a non-freefloating distal crown). Again, about the same distance means the samedistance from the proximal hub 228 +/−5 mm. (In preferred embodiments,the additional pair of cells 344 are located the same distance +/−3 mm,more preferably the same distance +/−0.5 mm, from the proximal hub 228).As best seen in FIGS. 36J and 36L, the additional pair of cells 344 mayadjoin the enlarged cells 262A, 262B formed by the proximal-most freedistal crowns 258A, 258B. Optionally, from at least the distal crowns ofthe additional pair of cells 344 to the proximal ends of the enlargedcells 262E, 262F formed by the succeeding free distal crowns 258E, 258F,the basket 246 has no cells other than the enlarged cells 262A-262F, thecells 250A-250F comprising the free distal crowns 258A-258F and theadditional pair of cells 344.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, the basket 246 may comprise a series of struts/bridge memorymetal strips 295 having a proximal end 334 attached to a distal crown ofa cell and a distal end 336 attached to a proximal crown of adistally-located cell. The proximal-most pair of bridge memory metalstrips 295 may be located at the 3 and 9 o'clock positions, the nextproximal-most pair of bridge memory metal strips 295 may be located atthe 12 and 6 o'clock positions, the succeeding proximal-most pair ofbridge memory metal strips may be located at the 3 and 9 o'clockpositions, so that the bridge memory strips 295, like the free distalcrowns 258A-258J, alternate along the distal body length 226. Each ofthe pair of bridge memory metal strips 295 may form part of at least oneenlarged cell 262A-262J. Optionally, the bridge memory metal strips 295are the sole distally-extending basket strips 291 attached to therespective proximal crowns and the sole proximally-extending basketstrips 291 attached to the respective distal crowns.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, each of the pair of bridge memory metal strips 295 may form partof two enlarged cells 262A-262J. As with prior embodiments, FIGS. 36 and37 illustrate that in the relaxed state the bridge memory metal strips295 may be substantially parallel to the distal body length 226.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, the plurality of distal cells 248D may be comprised of fourdistal cells 248D located about the same distance from the proximaljunction 228, each cell having a center 340, and the centers 340 of thecells 248D may be spaced at approximately 90 degree intervals about thedistal body perimeter 300, and each of said four distal cells 248D mayadjoin two of the other of said distal four cells 248D, as best seen inFIGS. 36C and 36D. Again, about the same distance means the samedistance from the proximal hub 228 +/−5 mm. (In preferred embodiments,the four distal cells 248D are located the same distance +/−3 mm, morepreferably the same distance +/−0.5 mm, from the proximal hub 228).Optionally, in the relaxed state, as best seen in FIGS. 36C and 36D,each of the four distal cells 248D comprises two lateral crowns 338pointing generally in a direction perpendicular to the distal bodylength 226 and each lateral crown 338 of one of said four cells 248Dadjoins a lateral crown 338 of an adjacent of said four cells 248D.

As with prior embodiments, FIGS. 36-37 illustrate that the distal body216 preferably has no more than four cells at any location along thedistal body length 226.

As with prior embodiments, FIGS. 36-37 illustrate that each of theenlarged cells 260A-260J may be approximately the same size.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, the basket interior 346 may be substantially hollow.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, the enlarged cells 262A, 262B formed by the proximal-most freedistal crowns 258A, 258B may be adjoining, the enlarged cells 262C, 262Dformed by the next proximal-most free distal crowns 258C, 258D may beadjoining and the enlarged cells 262E, 262F formed by the succeedingfree distal crowns 258E, 258F may be adjoining. Optionally, as shown inthe illustrations of FIGS. 36-37, in the relaxed state each of theenlarged cells 262C, 262D formed by the next proximal-most free distalcrowns 258C, 258D adjoins an enlarged cell 262A, 262B formed by aproximal-most free distal crown 258A, 258B and an enlarged cell 262E,262F formed by a succeeding free distal crown 258E, 258F.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, for at least some enlarged cells 262A-262J (preferably for eachenlarged cell, as shown in the illustrations), the free distal crown258A-258J may be aligned with the distal crown 307 located at the distalend 310 of the enlarged cell 262A-262J.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, the distal cells 248D may be substantially the same size andattached to the distal junction 236 by a basket strip 291 having aproximal end attached to a distal crown of a distal cell 248D and adistal end attached to the distal junction 236.

As with prior embodiments, FIGS. 36-37 illustrate that in the relaxedstate, the cells 250A-250J comprising the free distal crowns 258A-258Jmay be substantially the same size.

As with prior embodiments, the system of FIGS. 36-37 may be used in amethod of removing a blood clot from a blood vessel of an animal themethod comprising the steps of: a) providing the system; b) positioningthe system in the blood vessel; c) allowing the height 224 and width 225of the distal body 216 to increase; d) moving the blood clot into thebasket interior 346; and e) moving the distal body 216 proximally out ofthe blood vessel.

As with prior embodiments, in FIGS. 36-37, not all parts are labelled inevery drawing for clarity.

The embodiments of FIGS. 36-37 may include any feature described orshown with the prior embodiments. For example, as illustrated in FIGS.36-37, the proximal junction 228 and distal junction 236 may be locatedapproximately in the center of the distal body width 225 and distal bodyheight 224 in the relaxed state. Additionally, as illustrated in FIGS.36-37, each pair of enlarged cells 262A/262B; 262C/262D; 262E/262F;262G/262H; 262I/262J may be substantially aligned such that each pair ofenlarged cells 262A/262B; 262C/262D; 262E/262F; 262G/262H; 262I/262J andthe substantially hollow interior 346 create a void extending from oneside of the basket 246 through the substantially hollow interior 346 tothe opposite side of the basket 246. In addition, FIGS. 36-37 illustratethe previously mentioned and shown twisting proximal strips 252. Forexample, the proximal end 254 of a first proximal strip 252 may belocated at least about 65 degrees relative to the distal end 256 of thefirst proximal strip 252, the proximal end 254 of a second proximalstrip 252 may be located least about 65 degrees relative to the distalend 256 of the second proximal strip 252, and the first and secondproximal strips 252 may intersect adjacent and distal to the proximaljunction 228 and the intersection may be located approximately in thecenter of the first height 224 and first width 225 in the relaxed state.In addition, FIG. 37 illustrate that the distal body 216 may have a voidlocated between the proximal junction 228 and the cells 250A, 250Bcomprising the proximal-most free distal crowns 258A, 258B. In addition,FIGS. 36-37 illustrate that the basket 246 has a non-uniform outwardradial force from the proximal strips 252 to the basket distal end 302.As with prior embodiments, in the embodiments of FIGS. 36-37, the freedistal crowns of each pair of free distal crowns 258A/258B; 258C/258D;258E/258F; 258G/258H; 258I/258J may be configured to contact each otherwhen an exterior, external compressive force is exerted on the freedistal crowns 258A-258J when the distal body 216 is in the relaxedstate. As with prior embodiments, in the embodiments of FIGS. 36-37, theproximal junction 228 and distal junction 236 may be in the form oftubes. In addition, the distal body 216 may include thethree-dimensional openings 293 mentioned previously. As with the priorembodiments, in the embodiments of FIGS. 36 and 37, some or all of thefree distal crowns 258A-258J, as well as proximal and distal junctions228 and 236, may include x-ray markers, as previously described.

Having now described the invention in accordance with the requirementsof the patent statutes, those skilled in the art will understand how tomake changes and modifications to the disclosed embodiments to meettheir specific requirements or conditions. Changes and modifications maybe made without departing from the scope and spirit of the invention, asdefined and limited solely by the following claims. In particular,although the system has been exemplified for use in retrieving bloodclots, the system may be used to retrieve other objects from animallumens. In addition, the steps of any method described herein may beperformed in any suitable order and steps may be performedsimultaneously if needed.

Terms of degree such as “substantially”, “about” and “approximately” asused herein mean a reasonable amount of deviation of the modified termsuch that the end result is not significantly changed. For example,these terms can be construed as including a deviation of at least ±5% ofthe modified term if this deviation would not negate the meaning of theword it modifies.

What is claimed is:
 1. A system for removing objects from an interiorlumen of an animal, the system comprising: a pull wire having a proximalend and a distal end; a distal body attached to the pull wire, thedistal body comprising an interior, a perimeter, a proximal end, adistal end, a distal body length extending from the proximal end to thedistal end, a proximal junction forming the proximal end of the distalbody, a plurality of proximal strips, a basket comprised of a pluralityof cells formed by a plurality of basket strips, and a distal junctionforming a distal end of the basket, the basket comprising a basketinterior, each proximal strip having a distal end attached to a cell anda proximal end, the proximal ends of the proximal strips converging atthe proximal junction, the distal body having a relaxed state whereinthe distal body has a first height and a first width, and a collapsedstate wherein the distal body has a second height and a second width,the second height less than the first height, the second width less thanthe first width